510(k) Report

FDA applicant

Airway Management, Inc.

Dallas, TX6 decisions2006–20180 recalls

FDA records 6 decisions for Airway Management, Inc. (Dallas, TX) from 2006 to 2018: 6 510(k) clearances. Most are in product codes LRK (Device, Anti-Snoring) and PLC (Sleep Appliances With Patient Monitoring). Its devices cite 12 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Airway Management, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2012: 12016: 12018: 1
2007high 1 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Airway Management, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Airway Management, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • LRKDevice, Anti-Snoring4decisions
  • PLCSleep Appliances With Patient Monitoring1decision
  • BZDVentilator, Non-Continuous (Respirator)1decision

Whose devices does it build on?

Its devices cite 12 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 13 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K062951Tap Iii Anti-Snoring DeviceAirway Management, Inc. · 20066cite it
  • K060388Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with AttachmentAirway Management, Inc. · 20064cite it
  • K061732TAP-TAirway Management, Inc. · 20063cite it

What has FDA decided for it lately?

  • K181482myTAP2Airway Management, Inc. · 2018
  • K160239Tap 3, Tap 1Airway Management, Inc. · 2016
  • K122350Tap Pap Nasal Pillow MaskAirway Management, Inc. · 2012
  • K062951Tap Iii Anti-Snoring DeviceAirway Management, Inc. · 2006
  • K061732TAP-TAirway Management, Inc. · 2006
  • K060388Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with AttachmentAirway Management, Inc. · 2006

All 6 as Airway Management, Inc. →

Other applicant names beginning “Airway”

FDA records each applicant name separately; these may or may not be the same firm.

Airway Technologies D/B/A Airway Management 1Airway Products, Inc. 1