FDA product code FLG: Cleaner, Ultrasonic, Medical Instrument
FLG is the FDA product code for cleaner, ultrasonic, medical instrument. It is a Class I device, regulated under 21 CFR 880.6150 and reviewed by the General Hospital panel. FDA has cleared 19 510(k) submissions under FLG, from 12 different applicants. The average 510(k) review took 129 days (median 89). FDA has posted 7 recalls for FLG devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Cleaner, Ultrasonic, Medical Instrument |
| Device class | Class I |
| Regulation | 21 CFR 880.6150 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FLG clearance
Top FLG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Palmetto Chemical & Supply Co., Inc. | 4 | 1986-06-17 |
| Calgon Corp. | 3 | 1994-12-20 |
| Calgon Vestal Div. | 3 | 1994-10-19 |
| Medical Polymers, Inc. | 1 | 1994-04-15 |
| Surgicot, Inc. | 1 | 1994-04-13 |
7 more applicants have FLG clearances. See the full list in Caduvo.
Most recent FLG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K944950 | Calgon Corp. | KLENZYME | 1994-12-20 | 74 |
| K944494 | Calgon Vestal Div. | ALSA-KLENZ | 1994-10-19 | 36 |
| K944033 | Calgon Vestal Div. | BILL EVANS-KLENZ | 1994-10-07 | 51 |
| K940263 | Calgon Corp. | NPH-KLENZ | 1994-05-18 | 117 |
| K941163 | Calgon Vestal Div. | MON-KLENZ | 1994-05-18 | 68 |
Recalls for FLG devices
7 product recalls in 6 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-03-31.
| Year | Recalls |
|---|---|
| 2020 | 2 |
| 2024 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code FLG?
FLG is the FDA product code for cleaner, ultrasonic, medical instrument. It is a Class I device, regulated under 21 CFR 880.6150 and reviewed by the General Hospital panel.
What device class is FLG?
Class I, regulation 21 CFR 880.6150. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FLG?
Across 19 cleared submissions the average was 129 days from receipt to decision (median 89).
Which companies have the most FLG clearances?
Palmetto Chemical & Supply Co., Inc. (4); Calgon Corp. (3); Calgon Vestal Div. (3); Medical Polymers, Inc. (1); Surgicot, Inc. (1).
Have FLG devices been recalled?
Yes: 7 product recalls across 6 recall events; the most recent began 2025-03-31.
Next steps
- Run an FDA pathway report with predicate devices for product code FLG
- Run a recall and safety report across every FLG manufacturer
- Watch product code FLG 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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