FDA product code FSP: Loupe, Diagnostic/Surgical
FSP is the FDA product code for loupe, diagnostic/surgical. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 4 510(k) submissions under FSP, from 3 different applicants. The average 510(k) review took 18 days (median 18). FDA has posted 3 recalls for FSP devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Loupe, Diagnostic/Surgical |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FSP clearance
Top FSP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Luxtec Corp. | 2 | 1989-09-15 |
| Zinnanti Surgical Instruments, Inc. | 1 | 1989-04-12 |
| Keeler Instruments, Inc. | 1 | 1986-05-23 |
Most recent FSP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K895248 | Luxtec Corp. | IMS5000 ILLUMINATED LOUPES | 1989-09-15 | 25 |
| K891895 | Zinnanti Surgical Instruments, Inc. | SURGICAL LOUPES | 1989-04-12 | 19 |
| K864386 | Luxtec Corp. | LUXTEC LOUPES FOR SURGICAL VISION | 1986-11-17 | 12 |
| K861749 | Keeler Instruments, Inc. | 3X BLUE PANORAMIC LOUPES 13.5 WORKING DISTANCE | 1986-05-23 | 17 |
Recalls for FSP devices
3 product recalls in 2 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-07-03.
| Year | Recalls |
|---|---|
| 2025 | 2 |
Frequently asked questions
What is FDA product code FSP?
FSP is the FDA product code for loupe, diagnostic/surgical. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.
What device class is FSP?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FSP?
Across 4 cleared submissions the average was 18 days from receipt to decision (median 18).
Which companies have the most FSP clearances?
Luxtec Corp. (2); Zinnanti Surgical Instruments, Inc. (1); Keeler Instruments, Inc. (1).
Have FSP devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2025-07-03.
Next steps
- Run an FDA pathway report with predicate devices for product code FSP
- Run a recall and safety report across every FSP manufacturer
- Watch product code FSP 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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