Spiracur, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Spiracur, Inc.” (first 2011, latest 2015), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 102 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 | 3 | 137 |
| 2015 | 1 | 148 |
| 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 |
|---|---|---|---|
| OKO | Negative Pressure Wound Therapy Non-Powered Suction Apparatus | 9 | 8 |
Review panels
Most recent Spiracur, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K151710 | SNaP Wound Care System | OKO | 2015-11-19 | 148 |
| K142272 | SNaP Wound Care System | OKO | 2014-11-25 | 102 |
| K132080 | SNAP WOUND CARE SYSTEM | OKO | 2014-03-12 | 250 |
| K133137 | CISNAP CLOSED INCISION SYSTEM | OKO | 2014-02-25 | 137 |
| K113032 | SNAP WOUND CARE SYSTEM | OKO | 2011-12-01 | 50 |
| K112341 | SNAP WOUND CARE SYSTEM | OKO | 2011-08-29 | 14 |
| K111393 | SNAP (R) WOUND CARE SYSTEM | OKO | 2011-07-28 | 71 |
| K111006 | CI-SNAP WOUND CARE SYSTEM | OKO | 2011-07-21 | 101 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN080011 | De Novo | Negative Pressure Wound Therapy Non-Powered Suction Apparatus | 2009-08-07 |
Recalls
openFDA lists no recalls under a recalling firm named Spiracur, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Spiracur, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Spiracur, Inc.” (first 2011, latest 2015), plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Spiracur, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Spiracur, Inc. is 102 days.
Which FDA product codes appear under Spiracur, Inc.?
The most frequent FDA product codes under this applicant name are OKO (Negative Pressure Wound Therapy Non-Powered Suction Apparatus, 9).
Next steps
- See all 8 Spiracur, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OKO, Spiracur, 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.