Custom Medical Products, Ltd.: FDA clearances and approvals
Custom Medical Products, Ltd. has 14 FDA 510(k) clearances (first 1983, latest 2000), across 9 product codes in 5 review panels. Median 510(k) review time: 202 days.
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 |
|---|---|---|---|
| KKX | Drape, Surgical, Antimicrobial | 4 | 4 |
| FCE | Enema Kit | 2 | 2 |
| FYA | Gown, Surgical | 2 | 2 |
| HRX | Arthroscope | 1 | 1 |
| IZH | System, X-Ray, Mammographic | 1 | 1 |
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | 1 | 1 |
| IZS | Aperture, Radiographic | 1 | 1 |
| LRO | General Surgery Tray | 1 | 1 |
| MMP | Cover, Barrier, Protective | 1 | 1 |
Review panels
- General Hospital (7)
- Radiology (3)
- Gastroenterology and Urology (2)
- Orthopedic (1)
- General and Plastic Surgery (1)
Most recent Custom Medical Products, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K994199 | VARIOUS STERILE AND NON-STERILE SURGICAL DRAPES, (I.E., DISPOSABLES MINOR PROCEDURE DRAPES, LARGE APERTURE DRAPES, ABSOR | KKX | 2000-06-09 | 179 |
| K931417 | STERILE EQUIPMENT COVERS | MMP | 1995-07-06 | 836 |
| K931456 | SURGICAL DRAPE AND GOWN TRAY | FYA | 1994-07-08 | 472 |
| K931455 | HEAD SHEET | KKX | 1994-05-05 | 408 |
| K931418 | SURGICAL DRAPE | KKX | 1994-05-05 | 409 |
| K930815 | ABDOMINAL / THORACIC PATIENT DRAPE | KKX | 1994-05-05 | 442 |
| K931844 | CUSTOM PROCEDURE MEDICAL TRAY OR KIT | LRO | 1994-01-25 | 287 |
| K926519 | SURGICAL GOWN | FYA | 1993-08-12 | 225 |
| K900848 | ENEMA KIT 'STRAIGHT' DESIGN | FCE | 1990-04-13 | 50 |
| K900847 | ENEMA KIT 'Y' DESIGN | FCE | 1990-04-13 | 50 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Custom Medical Products, Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Custom Medical Products, Ltd. have?
Custom Medical Products, Ltd. has 14 FDA 510(k) clearances (first 1983, latest 2000), across 9 product codes in 5 review panels.
How long does FDA take to clear Custom Medical Products, Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Custom Medical Products, Ltd.'s cleared 510(k)s is 202 days.
What devices does Custom Medical Products, Ltd. make?
Its most frequent FDA product codes are KKX (Drape, Surgical, Antimicrobial, 4); FCE (Enema Kit, 2); FYA (Gown, Surgical, 2).
Has Custom Medical Products, Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Custom Medical Products, Ltd. Related entities may recall under other names.
Next steps
- See all 14 Custom Medical Products, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code KKX, Custom Medical Products, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.