FDA product code FMH: Container, Specimen, Sterile
FMH is the FDA product code for container, specimen, sterile. It is a Class I device, regulated under 21 CFR 864.3250 and reviewed by the General Hospital panel. FDA has cleared 23 510(k) submissions under FMH, from 18 different applicants. The average 510(k) review took 43 days (median 36). FDA has posted 21 recalls for FMH devices, 11 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Container, Specimen, Sterile |
| Device class | Class I |
| Regulation | 21 CFR 864.3250 |
| Review panel | HO — General Hospital |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FMH clearance
Top FMH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sage Products, Inc. | 4 | 1980-05-30 |
| Sherwood Medical Co. | 2 | 1981-11-06 |
| C.R. Bard, Inc. | 2 | 1978-02-21 |
| Tri-Tech, Inc. | 1 | 1990-09-17 |
| Cordis Corp. | 1 | 1983-01-19 |
13 more applicants have FMH clearances. See the full list in Caduvo.
Most recent FMH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K900983 | Tri-Tech, Inc. | TRI-TECH URINE SPECIMEN KIT | 1990-09-17 | 199 |
| K823763 | Cordis Corp. | VARIOUS-SPECIMEN COLLECTORS | 1983-01-19 | 36 |
| K820180 | Omnimedical | CALCULI FILTER CUP | 1982-02-05 | 14 |
| K812933 | Sherwood Medical Co. | LANCER SPECIMEN CONTAINER | 1981-11-06 | 17 |
| K802340 | American Pharmaseal Div. Ahsc | SPECIMEN SET | 1980-10-10 | 14 |
Recalls for FMH devices
21 product recalls in 18 recall events; 11 initiated in the last five years and 11 still open. Most recent: 2026-03-19.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2019 | 3 |
| 2020 | 1 |
| 2022 | 1 |
| 2023 | 3 |
| 2024 | 2 |
| 2025 | 2 |
| 2026 | 3 |
Frequently asked questions
What is FDA product code FMH?
FMH is the FDA product code for container, specimen, sterile. It is a Class I device, regulated under 21 CFR 864.3250 and reviewed by the General Hospital panel.
What device class is FMH?
Class I, regulation 21 CFR 864.3250. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FMH?
Across 23 cleared submissions the average was 43 days from receipt to decision (median 36).
Which companies have the most FMH clearances?
Sage Products, Inc. (4); Sherwood Medical Co. (2); C.R. Bard, Inc. (2); Tri-Tech, Inc. (1); Cordis Corp. (1).
Have FMH devices been recalled?
Yes: 21 product recalls across 18 recall events; the most recent began 2026-03-19.
Next steps
- Run an FDA pathway report with predicate devices for product code FMH
- Run a recall and safety report across every FMH manufacturer
- Watch product code FMH 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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