Spirometrics, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Spirometrics, Inc.” (first 1983, latest 1992), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 49 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 |
|---|---|---|---|
| BZG | Spirometer, Diagnostic | 4 | 4 |
| BTY | Calculator, Predicted Values, Pulmonary Function | 2 | 2 |
| BZH | Meter, Peak Flow, Spirometry | 1 | 1 |
| BZM | Calculator, Pulmonary Function Interpretor (Diagnostic) | 1 | 1 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 | 1 |
| CCJ | Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase | 1 | 1 |
| JAX | Pneumotachometer | 1 | 1 |
Review panels
- Anesthesiology (10)
- General Hospital (1)
Most recent Spirometrics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K915059 | PEAK FLOW MONITOR | BZH | 1992-07-27 | 262 |
| K911358 | CMD/DLCO DIAGNOSTIC SPIROMETER | BTY | 1991-07-22 | 116 |
| K900322 | CO/CMD-1 | CCJ | 1990-04-30 | 97 |
| K901057 | SPIROMETRICS MODEL 2600 MIRO SPIROMETER | BZG | 1990-04-03 | 28 |
| K900673 | SERIAL FLOW | BZG | 1990-04-03 | 49 |
| K884464 | SPIROMETRICS MODEL 2200 SM200 FLOW SENSOR | JAX | 1989-01-19 | 87 |
| K884465 | SPIROMETRICS MODEL 2141 SPIRO-FILTER(TM) | CAH | 1988-11-09 | 16 |
| K863953 | SPIROMETRICS MODEL 2500 FLOWMATE(TM) | BZM | 1987-01-15 | 97 |
| K850045 | SPIROMETRICS 2453 & SMI III | BTY | 1985-02-14 | 38 |
| K844333 | SPIROMETRICS 2451 & SMI I | BZG | 1984-11-20 | 13 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Spirometrics, 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.
- Spirometrics Medical Equipment Co. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Spirometrics, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Spirometrics, Inc.” (first 1983, latest 1992), across 7 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 Spirometrics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Spirometrics, Inc. is 49 days.
Which FDA product codes appear under Spirometrics, Inc.?
The most frequent FDA product codes under this applicant name are BZG (Spirometer, Diagnostic, 4); BTY (Calculator, Predicted Values, Pulmonary Function, 2); BZH (Meter, Peak Flow, Spirometry, 1).
Next steps
- See all 11 Spirometrics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BZG, Spirometrics, 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.