Thayer Medical Corp.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Thayer Medical Corp.” (first 1988, latest 2024), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 115 days. Since 2017 the median was 400 days, against 236 days for all cleared 510(k)s in the same product codes. 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 | 1 | 486 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 400 |
| 2023 | 0 | — |
| 2024 | 1 | 225 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Thayer Medical Corp. took a median 400 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 236 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | 9 | 9 |
| BYH | Drain, Tee (Water Trap) | 4 | 4 |
| NVP | Holding Chambers, Direct Patient Interface | 2 | 2 |
| BXR | Meter, Airway Pressure (Inspiratory Force) | 1 | 1 |
| BZA | Connector, Airway (Extension) | 1 | 1 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 1 | 1 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 1 | 1 |
Review panels
- Anesthesiology (19)
Most recent Thayer Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233553 | MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter | CAF | 2024-06-18 | 225 |
| K210558 | LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber | NVP | 2022-04-01 | 400 |
| K160109 | Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber | NVP | 2017-05-19 | 486 |
| K111570 | MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR | CAF | 2011-09-29 | 115 |
| K102658 | MINISPACER DUAL-SPRAY MDI ADAPTER WITH 22MM (OR 15MM) OD / 22MM OD/ID CONNECTIONS / 15MM ID CONNECTIONS | CAF | 2010-12-10 | 86 |
| K993101 | LITEAIRE | CAF | 2000-10-26 | 406 |
| K992722 | PRIMEAIRE | CAF | 1999-11-10 | 89 |
| K972237 | HAND HELD MEDISPACER | CAF | 1997-07-31 | 91 |
| K955805 | DUAL SPRAY MINISPACER | CAF | 1996-03-21 | 90 |
| K941026 | THAYER MASK TO MOUTHPIECE ADAPTER/CONNECTOR | BZA | 1994-08-18 | 167 |
9 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2016-09-29.
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 Thayer Medical Corp. (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Thayer Medical Corp.?
FDA lists 19 510(k) clearances under the applicant name “Thayer Medical Corp.” (first 1988, latest 2024), across 7 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Thayer Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Thayer Medical Corp. is 115 days. Since 2017: 400 days, versus 236 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Thayer Medical Corp.?
The most frequent FDA product codes under this applicant name are CAF (Nebulizer (Direct Patient Interface), 9); BYH (Drain, Tee (Water Trap), 4); NVP (Holding Chambers, Direct Patient Interface, 2).
Next steps
- See all 19 Thayer Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code CAF, Thayer Medical Corp.'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.