Sparco, Inc.: FDA clearances and approvals
Sparco, Inc. has 6 FDA 510(k) clearances (first 1984, latest 1988), across 4 product codes in 2 review panels. Median 510(k) review time: 24 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 |
|---|---|---|---|
| FEB | Accessories, Cleaning, For Endoscope | 1 | 1 |
| FSM | Tray, Surgical, Instrument | 1 | 1 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Sparco, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K884041 | MASTER-GUARD | KCT | 1988-10-07 | 11 |
| K863964 | LIMB-GUARD | — | 1986-10-24 | 14 |
| K850268 | SPARCO SCOPE GUARD | FEB | 1985-04-15 | 82 |
| K850267 | SPARCO PIGGY-BACK POLE-INTRAVENOUS TRANSPORT POLE | — | 1985-02-27 | 35 |
| K844286 | FLASH GUARD PLASTIC VERSION | FSM | 1984-11-19 | 14 |
| K841669 | FLASH GUARD | — | 1984-06-05 | 43 |
Recalls
openFDA lists no recalls under a recalling firm named Sparco, 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 Sparco, Inc. have?
Sparco, Inc. has 6 FDA 510(k) clearances (first 1984, latest 1988), across 4 product codes in 2 review panels.
How long does FDA take to clear Sparco, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Sparco, Inc.'s cleared 510(k)s is 24 days.
What devices does Sparco, Inc. make?
Its most frequent FDA product codes are FEB (Accessories, Cleaning, For Endoscope, 1); FSM (Tray, Surgical, Instrument, 1); KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, 1).
Has Sparco, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Sparco, Inc. Related entities may recall under other names.
Next steps
- See all 6 Sparco, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FEB, Sparco, 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.