FDA product code KFK: Saw, Pneumatically Powered
KFK is the FDA product code for saw, pneumatically powered. It is a Class I device, regulated under 21 CFR 878.4820 and reviewed by the General and Plastic Surgery panel. FDA has cleared 4 510(k) submissions under KFK, from 4 different applicants. The average 510(k) review took 44 days (median 42). FDA has posted 1 recall for KFK devices.
Classification
| Field | Value |
|---|---|
| Device name | Saw, Pneumatically Powered |
| Device class | Class I |
| Regulation | 21 CFR 878.4820 |
| 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 KFK clearance
Top KFK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medmark, Inc. | 1 | 1989-08-07 |
| Micro Surgical Instruments Corp. | 1 | 1989-08-03 |
| Micro-Aire Surgical Instruments, Inc. | 1 | 1987-02-24 |
| Amsco Co. | 1 | 1980-08-20 |
Most recent KFK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K893949 | Medmark, Inc. | #157 EXAM LIGHT | 1989-08-07 | 67 |
| K894301 | Micro Surgical Instruments Corp. | MICRO-AIRE STERNUM SAW 4800 | 1989-08-03 | 41 |
| K870157 | Micro-Aire Surgical Instruments, Inc. | OSCILLATING SAW/ RECIPROCATING SAW/ DRILL-REAMER | 1987-02-24 | 42 |
| K801737 | Amsco Co. | STERNUM SAW | 1980-08-20 | 26 |
Recalls for KFK devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2005-12-20.
Frequently asked questions
What is FDA product code KFK?
KFK is the FDA product code for saw, pneumatically powered. It is a Class I device, regulated under 21 CFR 878.4820 and reviewed by the General and Plastic Surgery panel.
What device class is KFK?
Class I, regulation 21 CFR 878.4820. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KFK?
Across 4 cleared submissions the average was 44 days from receipt to decision (median 42).
Which companies have the most KFK clearances?
Medmark, Inc. (1); Micro Surgical Instruments Corp. (1); Micro-Aire Surgical Instruments, Inc. (1); Amsco Co. (1).
Have KFK devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2005-12-20.
Next steps
- Run an FDA pathway report with predicate devices for product code KFK
- Run a recall and safety report across every KFK manufacturer
- Watch product code KFK 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 General and Plastic Surgery product codes · FDA product code lookup · 510(k) database search · 510(k) review times