Superior Healthcare Group, Inc.: FDA clearances and approvals
Superior Healthcare Group, Inc. has 14 FDA 510(k) clearances (first 1985, latest 1993), across 10 product codes in 3 review panels. Median 510(k) review time: 72 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 |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | 3 | 3 |
| LYY | Latex Patient Examination Glove | 3 | 3 |
| BSY | Catheters, Suction, Tracheobronchial | 1 | 1 |
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | 1 | 1 |
| FHN | Ligator, Hemorrhoidal | 1 | 1 |
| FMS | Bed, Pediatric Open Hospital | 1 | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
| JOL | Catheter And Tip, Suction | 1 | 1 |
| MNK | Endoscopic Bite Block | 1 | 1 |
| OCX | Endoscopic Irrigation/Suction System | 1 | 1 |
Review panels
Most recent Superior Healthcare Group, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K925530 | INSTRUMENT WARMER | FMS | 1993-06-18 | 228 |
| K924764 | OVERTUBE FOR ENDSCOPIC LIGATOR | MNK | 1993-03-15 | 173 |
| K905755 | NON-STERILE PATIENT EXAMINATION GLOVES | LYY | 1991-03-08 | 71 |
| K903347 | SODIUM CHLORIDE SOLUTION | FOZ | 1990-12-13 | 141 |
| K904216 | STERILE WATER SOLUTION CATALOG # 10000 | JOL | 1990-11-16 | 65 |
| K903340 | STERILE URETHRAL CATHETER PROCEDURE KITS | FCM | 1990-10-04 | 71 |
| K896321 | NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH. | BSY | 1989-11-13 | 12 |
| K894676 | STERILE LATEX EXAM GLOVES | LYY | 1989-08-17 | 24 |
| K891445 | LATEX EXAMINATION GLOVES | LYY | 1989-08-09 | 147 |
| K892426 | NO. 86500 - ENDOSCOPIC JET WASHER | OCX | 1989-06-22 | 73 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Superior Healthcare Group, 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 Superior Healthcare Group, Inc. have?
Superior Healthcare Group, Inc. has 14 FDA 510(k) clearances (first 1985, latest 1993), across 10 product codes in 3 review panels.
How long does FDA take to clear Superior Healthcare Group, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Superior Healthcare Group, Inc.'s cleared 510(k)s is 72 days.
What devices does Superior Healthcare Group, Inc. make?
Its most frequent FDA product codes are KNT (Tubes, Gastrointestinal (And Accessories), 3); LYY (Latex Patient Examination Glove, 3); BSY (Catheters, Suction, Tracheobronchial, 1).
Has Superior Healthcare Group, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Superior Healthcare Group, Inc. Related entities may recall under other names.
Next steps
- See all 14 Superior Healthcare Group, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KNT, Superior Healthcare Group, 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.