Fred Sammons, Inc.: FDA clearances and approvals
Fred Sammons, Inc. has 278 FDA 510(k) clearances (first 1976, latest 1988), across 58 product codes in 7 review panels. Median 510(k) review time: 17 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 |
|---|---|---|---|
| ILC | Utensil, Eating | 28 | 28 |
| KNO | Accessories, Wheelchair | 25 | 25 |
| ILH | Splint, Hand, And Components | 21 | 21 |
| ILP | System, Communication, Non-Powered | 18 | 18 |
| ION | Exerciser, Non-Measuring | 18 | 18 |
| ILS | Adaptor, Hygiene | 17 | 17 |
| ILD | Adaptor, Dressing | 14 | 14 |
| IKW | Utensil, Homemaking | 12 | 12 |
| IKX | Aid, Transfer | 8 | 8 |
| KQW | Goniometer, Nonpowered | 8 | 8 |
Plus 48 more product codes.
Review panels
- Physical Medicine (234)
- Neurology (18)
- General Hospital (7)
- Gastroenterology and Urology (5)
- Anesthesiology (1)
- Ophthalmic (1)
- General and Plastic Surgery (1)
Most recent Fred Sammons, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K880644 | ULTRA-PAN FOR ORTHOTIC PLASTICS (7262) | IRQ | 1988-05-06 | 80 |
| K880647 | ADULT PERCEPTUAL MOTOR PUZZLES (5331-01) | HOX | 1988-04-01 | 45 |
| K831549 | ARM SLINGS | ILI | 1983-06-30 | 49 |
| K831548 | SPLINTS | ILH | 1983-06-27 | 46 |
| K831550 | FINGER BONIOMETER BK7506 | KQW | 1983-06-24 | 43 |
| K831544 | DELUXE TRACTION EXERCISE GLOVE BK5035 | IOD | 1983-06-24 | 43 |
| K831543 | ADJUST. WEIGHTS-BK5171-05,10,20 BEOK | ION | 1983-06-24 | 43 |
| K831542 | ADJUSTABLE POLYCENTRIC ELBOW HINGE | IQI | 1983-06-24 | 43 |
| K831553 | LEG DRAINAGE BAG STRAP BK6011 | KNX | 1983-06-16 | 35 |
| K831552 | SORBOTHANE VISCO INNER SOLE PAD | KNP | 1983-06-08 | 27 |
268 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Fred Sammons, Inc..
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 Fred Sammons, Inc. have?
Fred Sammons, Inc. has 278 FDA 510(k) clearances (first 1976, latest 1988), across 58 product codes in 7 review panels.
How long does FDA take to clear Fred Sammons, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Fred Sammons, Inc.'s cleared 510(k)s is 17 days.
What devices does Fred Sammons, Inc. make?
Its most frequent FDA product codes are ILC (Utensil, Eating, 28); KNO (Accessories, Wheelchair, 25); ILH (Splint, Hand, And Components, 21).
Has Fred Sammons, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Fred Sammons, Inc. Related entities may recall under other names.
Next steps
- See all 278 Fred Sammons, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ILC, Fred Sammons, Inc.'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.