Air Next

K183089

NuvoAir AB · cleared 2020-01-02 · product code BZG · Anesthesiology

Premarket evidence — what FDA accepted

Device typehardware
source quote (p.4)
“Air Next is a hand-held spirometer, weighing only 75g and it is powered by 2 AAA alkaline 1.5V batteries. It consists of 3 main components: the Air Next device, the NuvoAir disposable turbine (delivered in one package) and the Air Next mobile application downloadable from Apple's and Google's Play Stores.”
AlgorithmThe algorithm in the firmware inside the Air Next device then converts the rotations into airflow measured in liters per second.
source quote (p.6)
“The algorithm in the firmware inside the Air Next device then converts the rotations into airflow measured in liters per second.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Bench

sample size not stated

endpoints: Volume accuracy; Volume range; Flow range; Flow accuracy; Flow resistance; Forced vital capacity (FVC); Volume expired in the first (FEV0.75, FEV1, FEV3, FEV6); Ratio between volume expired in a certain time period and FVC (FEV/FVC (FER) for 0.75/1/3/6); Peak expiratory flow (PEF); Forced expiratory flow between the first 25% and 75% of the FVC (FEF25-75 (MEF)); Volume inspired in the first second of the test (FIV1); Forced inspiratory volume (FIVC); Peak inspiratory flow (PIF); Forced inspiratory flow in the first 25% and 75% of the FIV (FIF25-75 (MIF25-75)); Ratio between FEV1 and FEV6; Forced expiratory flow at 50% of FVC divided by FVC (FEF50/FVC); Force inspiratory flow at first second device forced inspiratory volume (FIV1/FIVC (FIR)); Forced expiratory time (FET); Maximum voluntary ventilation (MVV (ind)); general requirements for basic safety and essential performance; Application of usability engineering to medical devices; Electromagnetic disturbances; Cytotoxicity; Irritation or Intracutaneous Reactivity; Irritation and Sensitization

standards: IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012, IEC 60601-1-6:2010, AMD1:2013, IEC 62366:2007, IEC 60601-1-2:2014 (ED. 4), ISO 10993-1, ISO10993-5, ISO10993-10, ATS/ERS 2005 guideline, ISO 14971:2007, IEC 62366:2007 + A1:2014, ISO 62304:2006/A1:2015, EN ISO 26782: 2009, EN ISO 23747:2015, FCC Part 15, Subpart B, C

Reported performance (2 observations)

accuracyas written: “Volume accuracy”stated without valueCI ±3% of reading or ±0.050 L, whichever is greater
source quote (p.7)
“±3% of reading or ±0.050 L, whichever is greater”
accuracyas written: “Flow accuracy”stated without valueCI ±5% or 200 mL/s
source quote (p.7)
“±5% or 200 mL/s”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

1
recalls in product code, 24mo
4
MAUDE reports in code, 12mo
+71%
vs code's own 3-yr baseline
1
drift signals on this device
  • recall_reason_pattern

    Software/algorithm-related recall in product code BZG (Baxter Healthcare Corporation, initiated 2024-10-11): "There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:95559

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Anesthesiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K183089