FDA product code CAL: Laryngoscope, Non-Rigid
CAL is the FDA product code for laryngoscope, non-rigid. It is a Class I device, regulated under 21 CFR 868.5530 and reviewed by the Anesthesiology panel. FDA has cleared 8 510(k) submissions under CAL, from 5 different applicants. The average 510(k) review took 44 days (median 21). FDA has posted 11 recalls for CAL devices.
Classification
| Field | Value |
|---|---|
| Device name | Laryngoscope, Non-Rigid |
| Device class | Class I |
| Regulation | 21 CFR 868.5530 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CAL clearance
Top CAL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Optical Corp. | 3 | 1980-10-10 |
| Pentax Precision Instrument Corp. | 2 | 1995-04-06 |
| Haemonetics Corp. | 1 | 1988-01-11 |
| Reichert-Jung, Inc. | 1 | 1985-07-29 |
| Olympus Corp. | 1 | 1985-05-23 |
Most recent CAL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K951195 | Pentax Precision Instrument Corp. | FI-10P | 1995-04-06 | 21 |
| K951194 | Pentax Precision Instrument Corp. | FI-10M | 1995-04-06 | 21 |
| K872895 | Haemonetics Corp. | HAEMONETICS CELL SAVER MINI SAVER AUTO. BLOOD SYS. | 1988-01-11 | 172 |
| K852994 | Reichert-Jung, Inc. | REICHERT FLEXIBLE LARYNGOSCOPE, MODEL LS-11 | 1985-07-29 | 14 |
| K850978 | Olympus Corp. | OLYMPUS LF-1 INTUBATION SCOPE | 1985-05-23 | 76 |
Recalls for CAL devices
11 product recalls in 4 recall events; 0 initiated in the last five years and 9 still open. Most recent: 2021-09-10.
| Year | Recalls |
|---|---|
| 2020 | 8 |
| 2021 | 1 |
Frequently asked questions
What is FDA product code CAL?
CAL is the FDA product code for laryngoscope, non-rigid. It is a Class I device, regulated under 21 CFR 868.5530 and reviewed by the Anesthesiology panel.
What device class is CAL?
Class I, regulation 21 CFR 868.5530. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CAL?
Across 8 cleared submissions the average was 44 days from receipt to decision (median 21).
Which companies have the most CAL clearances?
American Optical Corp. (3); Pentax Precision Instrument Corp. (2); Haemonetics Corp. (1); Reichert-Jung, Inc. (1); Olympus Corp. (1).
Have CAL devices been recalled?
Yes: 11 product recalls across 4 recall events; the most recent began 2021-09-10.
Next steps
- Run an FDA pathway report with predicate devices for product code CAL
- Run a recall and safety report across every CAL manufacturer
- Watch product code CAL 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.
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