FDA product code JAX: Pneumotachometer
JAX is the FDA product code for pneumotachometer. It is a Class II device, regulated under 21 CFR 868.2550 and reviewed by the Anesthesiology panel. FDA has cleared 8 510(k) submissions under JAX, from 7 different applicants. The average 510(k) review took 95 days (median 74). FDA has posted 1 recall for JAX devices.
Classification
| Field | Value |
|---|---|
| Device name | Pneumotachometer |
| Device class | Class II |
| Regulation | 21 CFR 868.2550 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JAX clearance
Top JAX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Research Development Corp. | 2 | 1979-11-16 |
| Sdi Diagnostics, Inc. | 1 | 2000-01-07 |
| Medical Associated Services, Inc. | 1 | 1992-08-26 |
| Spirometrics, Inc. | 1 | 1989-01-19 |
| Peace Medical, Inc. | 1 | 1985-09-03 |
2 more applicants have JAX clearances. See the full list in Caduvo.
Most recent JAX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K990962 | Sdi Diagnostics, Inc. | FLOSENSE, MODEL 29-8010 | 2000-01-07 | 291 |
| K921178 | Medical Associated Services, Inc. | PTI-A, PTI-P, PTI-N DISPOSABLE PNEUMOTACHS | 1992-08-26 | 170 |
| K884464 | Spirometrics, Inc. | SPIROMETRICS MODEL 2200 SM200 FLOW SENSOR | 1989-01-19 | 87 |
| K853085 | Peace Medical, Inc. | PAX METER | 1985-09-03 | 42 |
| K833265 | Thoratec Laboratories Corp. | RESPIRATORY FLOW MODULE | 1983-11-28 | 68 |
Recalls for JAX devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2007-01-09.
Frequently asked questions
What is FDA product code JAX?
JAX is the FDA product code for pneumotachometer. It is a Class II device, regulated under 21 CFR 868.2550 and reviewed by the Anesthesiology panel.
What device class is JAX?
Class II, regulation 21 CFR 868.2550. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JAX?
Across 8 cleared submissions the average was 95 days from receipt to decision (median 74).
Which companies have the most JAX clearances?
Research Development Corp. (2); Sdi Diagnostics, Inc. (1); Medical Associated Services, Inc. (1); Spirometrics, Inc. (1); Peace Medical, Inc. (1).
Have JAX devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2007-01-09.
Next steps
- Run an FDA pathway report with predicate devices for product code JAX
- Run a recall and safety report across every JAX manufacturer
- Watch product code JAX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Anesthesiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times