Airway Management, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Airway Management, Inc.” (first 2006, latest 2018), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 88 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 90 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 191 |
| 2017 | 0 | — |
| 2018 | 1 | 87 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Airway Management, Inc. took a median 87 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 180 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LRK | Device, Anti-Snoring | 4 | 4 |
| BZD | Ventilator, Non-Continuous (Respirator) | 1 | 1 |
| PLC | Sleep Appliances With Patient Monitoring | 1 | 1 |
Review panels
- Dental (5)
- Anesthesiology (1)
Most recent Airway Management, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K181482 | myTAP2 | LRK | 2018-08-31 | 87 |
| K160239 | TAP 3, TAP 1 | PLC | 2016-08-10 | 191 |
| K122350 | TAP PAP NASAL PILLOW MASK | BZD | 2012-11-01 | 90 |
| K062951 | TAP III ANTI-SNORING DEVICE | LRK | 2006-12-12 | 74 |
| K061732 | TAP-T | LRK | 2006-07-12 | 22 |
| K060388 | TAP II ANTI-SNORING AND OBSTRUCTIVE SLEEP APNEA ORAL APPLIANCE WITH ATTACHMENT | LRK | 2006-05-17 | 92 |
Recalls
openFDA lists no recalls under a recalling firm named Airway Management, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Airway Products, Inc. (1 510(k)s)
- Airway Technologies D/B/A Airway Management (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Airway Management, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Airway Management, Inc.” (first 2006, latest 2018), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Airway Management, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Airway Management, Inc. is 88 days.
Which FDA product codes appear under Airway Management, Inc.?
The most frequent FDA product codes under this applicant name are LRK (Device, Anti-Snoring, 4); BZD (Ventilator, Non-Continuous (Respirator), 1); PLC (Sleep Appliances With Patient Monitoring, 1).
Next steps
- See all 6 Airway Management, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LRK, Airway Management, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.