Salter Labs: FDA filings under this applicant name
FDA lists 50 510(k) clearances under the applicant name “Salter Labs” (first 1978, latest 2026), across 20 product codes in 2 review panels. Median 510(k) review time under this name: 72 days. Since 2017 the median was 281 days, against 232 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 | 2 | 256 |
| 2016 | 3 | 281 |
| 2017 | 1 | 456 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 281 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 93 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Salter Labs took a median 281 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 232 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | 9 | 9 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 8 | 8 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 5 | 5 |
| NFB | Conserver, Oxygen | 4 | 4 |
| BZD | Ventilator, Non-Continuous (Respirator) | 3 | 3 |
| CAT | Cannula, Nasal, Oxygen | 3 | 3 |
| BYG | Mask, Oxygen | 2 | 2 |
| CCN | Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge | 2 | 2 |
| CCQ | Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | 2 | 2 |
| MNR | Ventilatory Effort Recorder | 2 | 2 |
Plus 10 more product codes.
Review panels
- Anesthesiology (49)
- General Hospital (1)
Most recent Salter Labs 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261389 | PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) | CCL | 2026-07-30 | 93 |
| K190878 | Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff, Trach- Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff | BTR | 2020-01-10 | 281 |
| K161719 | Salter Labs Bubble Humidifier | BTT | 2017-09-21 | 456 |
| K151874 | BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal | MNR | 2016-04-15 | 281 |
| K151506 | Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula | NFB | 2016-03-11 | 281 |
| K151421 | Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines | CCK | 2016-03-10 | 287 |
| K143700 | CPAP Cannulaide | BZD | 2015-08-05 | 224 |
| K142416 | Luma Wrap | PDH | 2015-06-12 | 288 |
| K092685 | PNEUMOTHERML, MODEL: 5800 | BZQ | 2009-11-24 | 83 |
| K051313 | BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCER | MNR | 2005-09-15 | 119 |
40 earlier clearances. See the full list in Caduvo.
Recalls
7 product recalls in 7 recall events; 0 initiated in the last five years. Most recent: 2016-01-05.
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 Salter Labs (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.
- Salter Instrumentation, Inc. (1 510(k)s)
- Salter Labs, Arvin Facility (1 510(k)s)
- Salter Labs, Division of Regulatory Affairs (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Salter Labs?
FDA lists 50 510(k) clearances under the applicant name “Salter Labs” (first 1978, latest 2026), across 20 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 Salter Labs?
The median time from FDA receipt to decision across 510(k)s cleared under the name Salter Labs is 72 days. Since 2017: 281 days, versus 232 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Salter Labs?
The most frequent FDA product codes under this applicant name are CAF (Nebulizer (Direct Patient Interface), 9); CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, 8); CCL (Analyzer, Gas, Oxygen, Gaseous-Phase, 5).
Next steps
- See all 50 Salter Labs clearances with predicates and recalls
- Run predicate analysis for product code CAF, Salter Labs'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.