VISIONAIR

K221892

PacificMD Biotech Llc · cleared 2022-10-05 · product code BXQ · Anesthesiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“The VISIONAIR™ system is a software application intended to be used with third-party endoscopic systems in the measurement of the nasal respiratory airway.”
AlgorithmAI algorithm which performs the Internal Nasal Valve and Nasal Cavum cross-section area segmentations
source quote (p.5)
“The VISIONAIR™ algorithm which performs the Internal Nasal Valve and Nasal Cavum cross-section area segmentations. The VISIONAIR™ application automatically analyzes the endoscopic images using its trained AI algorithm to measure the nasal valve and nasal cavum surface areas. Windows based GUI and AI written in Python 3.6 language.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
source quote (p.6)
“The USB KEY adds another level of security for the data management file system by allowing the user to physically have possession of the database encryption key all the time. The smart device and USB KEY both consist of encryption keys which are used to translate unique IDs to patient information and vice versa. The database, whether stored locally on the smart device, or to the cloud via the REAl module, never stores any of the patient's information without encrypting them.”

Validation studies (2)

Bench

sample size not stated

endpoints: Comparison of endoscopic image cross-sectional areas

Bench

sample size not stated

endpoints: Comparison of segmented endoscopic images

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

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

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

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/K221892