Hydro-Med Products, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Hydro-Med Products, Inc.” (first 1978, latest 1994), across 12 product codes in 5 review panels. Median 510(k) review time under this name: 92 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FEM | Accessories, Photographic, For Endoscope (Exclude Light Sources) | 1 | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| ILO | Pack, Hot Or Cold, Water Circulating | 1 | 1 |
| IPM | Cover, Limb | 1 | 1 |
| IWQ | Curtain, Protective, Radiographic | 1 | 1 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 | 1 |
| KME | Bedding, Disposable, Medical | 1 | 1 |
| KQM | Camera, Surgical And Accessories | 1 | 1 |
| LPZ | Container, Frozen Donor Tissue Storage | 1 | 1 |
Plus 2 more product codes.
Review panels
- General Hospital (5)
- Physical Medicine (2)
- Radiology (2)
- Gastroenterology and Urology (1)
- General and Plastic Surgery (1)
Most recent Hydro-Med Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K944198 | SURGICAL MICROSCOPE DRAPE | MMP | 1994-11-27 | 90 |
| K940151 | ULTRASOUND PROBE DRAPE | IYO | 1994-11-14 | 315 |
| K940152 | CAMERA COVER WITH TEAR TIP | FEM | 1994-10-28 | 298 |
| K934630 | UNIVERSAL VIDEO/LASER ARM DRAPE | KKX | 1994-10-28 | 399 |
| K923099 | X-RAY DRAPES | IWQ | 1992-10-15 | 112 |
| K863872 | TAMPER HAMPER | LPZ | 1987-02-10 | 130 |
| K853281 | EASYTOP | — | 1985-08-21 | 16 |
| K842304 | THE PATHFINDER | — | 1984-08-01 | 51 |
| K834407 | STERILE DISPOSABLE SPINAL NEEDLES | FMI | 1984-03-19 | 96 |
| K812405 | STERILE TV CAMERA & CORD COVER | KQM | 1981-10-20 | 60 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Hydro-Med Products, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Hydro-Med Products, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Hydro-Med Products, Inc.” (first 1978, latest 1994), across 12 product codes in 5 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Hydro-Med Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hydro-Med Products, Inc. is 92 days.
Which FDA product codes appear under Hydro-Med Products, Inc.?
The most frequent FDA product codes under this applicant name are FEM (Accessories, Photographic, For Endoscope (Exclude Light Sources), 1); FMI (Needle, Hypodermic, Single Lumen, 1); ILO (Pack, Hot Or Cold, Water Circulating, 1).
Next steps
- See all 13 Hydro-Med Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FEM, Hydro-Med Products, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.