Surgi-Med, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Surgi-Med, Inc.” (first 1987, latest 1988), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 74 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 |
|---|---|---|---|
| FNL | Bed, Ac-Powered Adjustable Hospital | 3 | 3 |
| IKZ | Bed, Patient Rotation, Powered | 1 | 1 |
| INX | Bed, Air Fluidized | 1 | 1 |
Review panels
Most recent Surgi-Med, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K881705 | MODEL 5000 AIR-FLUIDIZED SUPPORT SYSTEM | INX | 1988-07-13 | 85 |
| K873047 | KEANE MOBILITY BED | IKZ | 1987-10-15 | 72 |
| K872923 | PARAGON 9000 TILT AND TURN BED | FNL | 1987-10-14 | 79 |
| K872924 | PARAGON 8500 CARDIO-PULMONARY BED | FNL | 1987-10-09 | 74 |
| K872925 | MEGABED 1000 | FNL | 1987-09-15 | 50 |
Recalls
openFDA lists no recalls under a recalling firm named Surgi-Med, 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Surgi-Vision, Inc. (9 510(k)s)
- Surgi-Quip Inc.U (8 510(k)s)
- Surgi-Aid Endoscopics, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Surgi-Med, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Surgi-Med, Inc.” (first 1987, latest 1988), across 3 product codes in 2 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 Surgi-Med, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Surgi-Med, Inc. is 74 days.
Which FDA product codes appear under Surgi-Med, Inc.?
The most frequent FDA product codes under this applicant name are FNL (Bed, Ac-Powered Adjustable Hospital, 3); IKZ (Bed, Patient Rotation, Powered, 1); INX (Bed, Air Fluidized, 1).
Next steps
- See all 5 Surgi-Med, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FNL, Surgi-Med, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.