Mcgaw Respiratory Therapy: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Mcgaw Respiratory Therapy” (first 1976, latest 1977), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 9 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | 4 | 4 |
| BTR | Tube, Tracheal (W/Wo Connector) | 1 | 1 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 1 | 1 |
| CBD | Bottle, Collection, Breathing System (Calibrated) | 1 | 1 |
| CCI | Analyzer, Gas, Nitrogen, Gaseous-Phase | 1 | 1 |
Review panels
- Anesthesiology (7)
- General Hospital (1)
Most recent Mcgaw Respiratory Therapy 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K771550 | MRT DISPENSOR | CAF | 1977-09-20 | 39 |
| K771516 | CAPILLARY SAMPLE LINE | CCI | 1977-08-16 | 8 |
| K770665 | VALVE, PRESSURE, DEMAND | CBD | 1977-04-15 | 7 |
| K770286 | VENTILATOR BREATHING CIRCUIT | CAI | 1977-02-25 | 11 |
| K761300 | NEBULIZER CONTROL UNIT | CAF | 1976-12-30 | 9 |
| K761299 | DISPOSABLE NEBULIZER | CAF | 1976-12-30 | 9 |
| K761298 | PRE-FILLED DISPOSABLE NEBULIZER | CAF | 1976-12-30 | 9 |
| K760998 | ENDOTRACHAEL TUBE AND HOLDER | BTR | 1976-11-19 | 11 |
Recalls
openFDA lists no recalls under a recalling firm named Mcgaw Respiratory Therapy.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Mcgaw Respiratory Therapy (a text match, not an official crosswalk):
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.
- Mcgaw, Inc. (13 510(k)s)
- Mcgaw Laboratories (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Mcgaw Respiratory Therapy?
FDA lists 8 510(k) clearances under the applicant name “Mcgaw Respiratory Therapy” (first 1976, latest 1977), across 5 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 Mcgaw Respiratory Therapy?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mcgaw Respiratory Therapy is 9 days.
Which FDA product codes appear under Mcgaw Respiratory Therapy?
The most frequent FDA product codes under this applicant name are CAF (Nebulizer (Direct Patient Interface), 4); BTR (Tube, Tracheal (W/Wo Connector), 1); CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece), 1).
Next steps
- See all 8 Mcgaw Respiratory Therapy clearances with predicates and recalls
- Run predicate analysis for product code CAF, Mcgaw Respiratory Therapy'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.