FDA product code FNY: Basin, Emesis
FNY is the FDA product code for basin, emesis. It is a Class I device, regulated under 21 CFR 880.6730 and reviewed by the General Hospital panel. FDA has cleared 9 510(k) submissions under FNY, from 7 different applicants. The average 510(k) review took 71 days (median 61). FDA has posted 1 recall for FNY devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Basin, Emesis |
| Device class | Class I |
| Regulation | 21 CFR 880.6730 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every FNY clearance
Top FNY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Landmark Plastics | 3 | 1976-11-12 |
| American Hospital Supply Corp. | 1 | 1984-04-23 |
| Texas Medical Products, Inc. | 1 | 1980-10-31 |
| Premium Plastics, Inc. | 1 | 1980-04-29 |
| Procter & Gamble Mfg. Co. | 1 | 1980-01-16 |
2 more applicants have FNY clearances. See the full list in Caduvo.
Most recent FNY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K832826 | American Hospital Supply Corp. | AAP DOSIMETRY RELEASE OR BASIN SETS | 1984-04-23 | 248 |
| K802538 | Texas Medical Products, Inc. | BASIN PACK | 1980-10-31 | 16 |
| K800440 | Premium Plastics, Inc. | STERILE SPONGE BOWLS | 1980-04-29 | 61 |
| K792625 | Procter & Gamble Mfg. Co. | STERILIZATION PROCESS/PLACENTA BASIN | 1980-01-16 | 28 |
| K771733 | Bemis Health Care | 8 EMESIS BASIN | 1977-09-28 | 13 |
Recalls for FNY devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-05-30.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code FNY?
FNY is the FDA product code for basin, emesis. It is a Class I device, regulated under 21 CFR 880.6730 and reviewed by the General Hospital panel.
What device class is FNY?
Class I, regulation 21 CFR 880.6730. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FNY?
Across 9 cleared submissions the average was 71 days from receipt to decision (median 61).
Which companies have the most FNY clearances?
Landmark Plastics (3); American Hospital Supply Corp. (1); Texas Medical Products, Inc. (1); Premium Plastics, Inc. (1); Procter & Gamble Mfg. Co. (1).
Have FNY devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2023-05-30.
Next steps
- Run an FDA pathway report with predicate devices for product code FNY
- Run a recall and safety report across every FNY manufacturer
- Watch product code FNY 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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