Sterile Concepts, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Sterile Concepts, Inc.” (first 1992, latest 1995), across 9 product codes in 4 review panels. Median 510(k) review time under this name: 96 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 |
|---|---|---|---|
| LRO | General Surgery Tray | 2 | 2 |
| EIA | Unit, Operative Dental | 1 | 1 |
| FRG | Wrap, Sterilization | 1 | 1 |
| GAN | Suture, Absorbable, Synthetic | 1 | 1 |
| KDD | Kit, Surgical Instrument, Disposable | 1 | 1 |
| KMK | Device, Intravascular Catheter Securement | 1 | 1 |
| KNA | Instrument, Manual, Specialized Obstetric-Gynecologic | 1 | 1 |
| LYY | Latex Patient Examination Glove | 1 | 1 |
| MCZ | Suture Removal Kit | 1 | 1 |
Review panels
Most recent Sterile Concepts, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K951231 | ORTHOPEDIC PACKS | GAN | 1995-12-01 | 256 |
| K951081 | OB/GYN PACKS | KNA | 1995-11-13 | 249 |
| K952539 | RADIOLOGY PACKS | LRO | 1995-07-14 | 44 |
| K951478 | GENERAL AND PLASTIC SURGERY PACKS | LRO | 1995-06-13 | 75 |
| K944139 | DENTAL HYGIENE TRAY | LYY | 1994-12-15 | 113 |
| K943047 | IV START KITS | KMK | 1994-09-14 | 79 |
| K943090 | SUTURE REMOVAL TRAYS | FRG | 1994-08-22 | 55 |
| K940864 | DENTIST WITH ASSISTANT PACK | EIA | 1994-08-02 | 160 |
| K943046 | SKIN STAPLE REMOVAL TRAYS | MCZ | 1994-07-29 | 32 |
| K920763 | LACERATTION TRAY | KDD | 1992-09-28 | 222 |
Recalls
openFDA lists no recalls under a recalling firm named Sterile Concepts, 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.
- Sterile Design, Inc. (10 510(k)s)
- Sterile Containment Technology, LLC (1 510(k)s)
- Sterile Medical Systems (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sterile Concepts, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Sterile Concepts, Inc.” (first 1992, latest 1995), across 9 product codes in 4 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 Sterile Concepts, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sterile Concepts, Inc. is 96 days.
Which FDA product codes appear under Sterile Concepts, Inc.?
The most frequent FDA product codes under this applicant name are LRO (General Surgery Tray, 2); EIA (Unit, Operative Dental, 1); FRG (Wrap, Sterilization, 1).
Next steps
- See all 10 Sterile Concepts, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LRO, Sterile Concepts, 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.