Timeter Instrument Corp.: FDA filings under this applicant name
FDA lists 29 510(k) clearances under the applicant name “Timeter Instrument Corp.” (first 1976, latest 1988), across 15 product codes in 2 review panels. Median 510(k) review time under this name: 30 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 |
|---|---|---|---|
| CAX | Flowmeter, Tube, Thorpe, Back-Pressure Compensated | 6 | 6 |
| BYX | Tubing, Pressure And Accessories | 5 | 5 |
| BTI | Compressor, Air, Portable | 4 | 4 |
| BXX | Calibrator, Pressure, Gas | 2 | 2 |
| CAW | Generator, Oxygen, Portable | 2 | 2 |
| BTY | Calculator, Predicted Values, Pulmonary Function | 1 | 1 |
| BXP | Transducer, Gas Flow | 1 | 1 |
| BXW | Calibrator, Volume, Gas | 1 | 1 |
| BYK | Tent, Oxygen, Electrically Powered | 1 | 1 |
| BZK | Spirometer, Monitoring (W/Wo Alarm) | 1 | 1 |
Plus 5 more product codes.
Review panels
- Anesthesiology (28)
- General Hospital (1)
Most recent Timeter Instrument Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K875075 | RT-200 COMPUTER INTERFACE | BXX | 1988-04-21 | 134 |
| K875074 | VACUMATE INTERMITTENT/CONTINUOUS CONTROLLER,VM2000 | KDP | 1988-02-22 | 75 |
| K871603 | CRITERION II & IIA OXYGEN CONCENTRATORS | CAW | 1987-08-13 | 111 |
| K864836 | L.A.P. SPIROMETER | BTY | 1987-03-06 | 87 |
| K834274 | CRITERION I | CAW | 1984-04-13 | 127 |
| K823775 | BORDON GAGE REGULATOR #BG | CCN | 1983-01-14 | 31 |
| K822746 | RT-200 CALIBRATION ANALYZER | BXX | 1982-10-13 | 33 |
| K812766 | PCS-5 ACCESSORIES | BTI | 1981-12-17 | 73 |
| K813235 | DISS FEMALE AIR ADAPTOR | BYK | 1981-12-08 | 21 |
| K813234 | OHIO AIR ADAPTOR | BYX | 1981-12-08 | 21 |
19 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Timeter Instrument Corp..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Timeter Instrument Corp.?
FDA lists 29 510(k) clearances under the applicant name “Timeter Instrument Corp.” (first 1976, latest 1988), across 15 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 Timeter Instrument Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Timeter Instrument Corp. is 30 days.
Which FDA product codes appear under Timeter Instrument Corp.?
The most frequent FDA product codes under this applicant name are CAX (Flowmeter, Tube, Thorpe, Back-Pressure Compensated, 6); BYX (Tubing, Pressure And Accessories, 5); BTI (Compressor, Air, Portable, 4).
Next steps
- See all 29 Timeter Instrument Corp. clearances with predicates and recalls
- Run predicate analysis for product code CAX, Timeter Instrument 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.