Opportunity, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Opportunity, Inc.” (first 1997, latest 1997), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 176 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 |
|---|---|---|---|
| EFQ | Gauze/Sponge, Internal | 2 | 2 |
| KMF | Bandage, Liquid | 2 | 2 |
| LRO | General Surgery Tray | 2 | 2 |
| KKX | Drape, Surgical, Antimicrobial | 1 | 1 |
| MGP | Dressing, Wound And Burn, Occlusive | 1 | 1 |
Review panels
Most recent Opportunity, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K971095 | OPPORTUNITY SUTURE REMOVAL KIT | EFQ | 1997-09-16 | 176 |
| K971093 | OPPORTUNITY I.V. START KIT | MGP | 1997-09-16 | 176 |
| K971091 | OPPURTUNITY TRACHEOSTOMY CARE KIT | KMF | 1997-09-16 | 176 |
| K971090 | OPPORTUNITY DRESSING CHANGE TRAY | KMF | 1997-09-16 | 176 |
| K971089 | OPPORTUNITY, INC. LACERATION TRAY | KKX | 1997-09-16 | 176 |
| K971088 | OPPORTUNITY INCISION AND DRAINAGE TRAY | EFQ | 1997-09-16 | 176 |
| K971061 | OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY | LRO | 1997-06-11 | 79 |
| K971062 | OPPORTUNITY INC. GENERAL PURPOSE TRAY | LRO | 1997-06-09 | 77 |
Recalls
openFDA lists no recalls under a recalling firm named Opportunity, 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.
- Opportunity Resources, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Opportunity, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Opportunity, Inc.” (first 1997, latest 1997), across 5 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 Opportunity, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Opportunity, Inc. is 176 days.
Which FDA product codes appear under Opportunity, Inc.?
The most frequent FDA product codes under this applicant name are EFQ (Gauze/Sponge, Internal, 2); KMF (Bandage, Liquid, 2); LRO (General Surgery Tray, 2).
Next steps
- See all 8 Opportunity, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EFQ, Opportunity, 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.