Spsmedical Supply Corp.: FDA clearances and approvals
Spsmedical Supply Corp. has 28 FDA 510(k) clearances (first 1989, latest 2013), across 3 product codes in 1 review panel. Median 510(k) review time: 168 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 245 |
| 2013 | 2 | 330 |
| 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 |
|---|---|---|---|
| JOJ | Indicator, Physical/Chemical Sterilization Process | 17 | 17 |
| FRC | Indicator, Biological Sterilization Process | 9 | 9 |
| MRB | Indicator, Biological, Liquid Chemical Sterilization Process | 2 | 2 |
Review panels
- General Hospital (28)
Most recent Spsmedical Supply Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K122024 | SPSMEDICAL SPORVIEW 10 STEAM SELF CONTAINED BIOLOGICAL INDICATOR | FRC | 2013-11-26 | 503 |
| K130211 | AIRVIEW BOWIE DICK; TEST PACK, INDICATOR SHEETS | JOJ | 2013-07-05 | 157 |
| K111515 | SPSMEDICAL SPORVIEW STEAM BI | FRC | 2012-02-01 | 245 |
| K110152 | SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORS | JOJ | 2011-04-15 | 86 |
| K102363 | SPSMEDICAL EMPLUS 270 F STEAM EMULATOR MODEL EMP-104, EMP-1004 | JOJ | 2011-01-27 | 160 |
| K090650 | SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORS | JOJ | 2009-10-09 | 212 |
| K081879 | SPSMEDICAL SPORVIEW PA CULTURE SET | MRB | 2008-07-30 | 28 |
| K070595 | SPORVIEW STEAM SELF-CONTAINED BIOLOGICAL INDICATOR | FRC | 2007-05-24 | 83 |
| K063799 | STEAMPLUS STEAM INTEGRATOR | JOJ | 2007-01-05 | 14 |
| K051173 | SPSMEDICAL SPORVIEW PLUS STEAM BI TEST PACK | FRC | 2005-05-27 | 21 |
18 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Spsmedical Supply Corp..
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 Spsmedical Supply Corp. have?
Spsmedical Supply Corp. has 28 FDA 510(k) clearances (first 1989, latest 2013), across 3 product codes in 1 review panel.
How long does FDA take to clear Spsmedical Supply Corp.'s 510(k)s?
The median time from FDA receipt to decision across Spsmedical Supply Corp.'s cleared 510(k)s is 168 days.
What devices does Spsmedical Supply Corp. make?
Its most frequent FDA product codes are JOJ (Indicator, Physical/Chemical Sterilization Process, 17); FRC (Indicator, Biological Sterilization Process, 9); MRB (Indicator, Biological, Liquid Chemical Sterilization Process, 2).
Has Spsmedical Supply Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Spsmedical Supply Corp. Related entities may recall under other names.
Next steps
- See all 28 Spsmedical Supply Corp. clearances with predicates and recalls
- Run predicate analysis for product code JOJ, Spsmedical Supply Corp.'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.