Reprocessing Products Corp: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Reprocessing Products Corp” (first 1995, latest 2013), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 246 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 | 1 | 99 |
| 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 |
|---|---|---|---|
| MSY | Strip, Test, Reagent, Residuals For Dialysate, Disinfectant | 2 | 2 |
| FJD | Detector, Leak, Blood | 1 | 1 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 1 | 1 |
| LIF | Dialyzer Reprocessing System | 1 | 1 |
| MNV | Strip, Dialysate Ph Indicator | 1 | 1 |
Review panels
Most recent Reprocessing Products Corp 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K123805 | E-Z CHEK BLOOD LEAK TEST STRIPS | FJD | 2013-03-20 | 99 |
| K101750 | RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH TEST STRIPS, MODEL K100-0104 | MNV | 2011-01-07 | 199 |
| K090338 | ULTRA LOW TOTAL CHLORINE, E-Z CHEK SENSITIVE TOTAL CHLORINE | MSY | 2009-05-08 | 87 |
| K974426 | POTENCY TEST STRIPS, INDICATOR TEST STRIPS | LIF | 1999-02-10 | 471 |
| K974064 | MICRO X RESIDUAL TEST STRIPS | MSY | 1998-12-07 | 406 |
| K950602 | PORT CAPS (PROTECTIVE CLOSURES FOE REPROCESSED HEMODIALYZERS | FJI | 1995-11-30 | 294 |
Recalls
openFDA lists no recalls under a recalling firm named Reprocessing Products Corp.
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.
- Reprocessing Products Corporation (Rpc) (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Reprocessing Products Corp?
FDA lists 6 510(k) clearances under the applicant name “Reprocessing Products Corp” (first 1995, latest 2013), across 5 product codes 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 Reprocessing Products Corp?
The median time from FDA receipt to decision across 510(k)s cleared under the name Reprocessing Products Corp is 246 days.
Which FDA product codes appear under Reprocessing Products Corp?
The most frequent FDA product codes under this applicant name are MSY (Strip, Test, Reagent, Residuals For Dialysate, Disinfectant, 2); FJD (Detector, Leak, Blood, 1); FJI (Dialyzer, Capillary, Hollow Fiber, 1).
Next steps
- See all 6 Reprocessing Products Corp clearances with predicates and recalls
- Run predicate analysis for product code MSY, Reprocessing Products Corp'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.