Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Reprocessing Products Corp — Predicate Candidate Screening

6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

294 daysmedian FDA review time
471 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K123805E-Z CHEK BLOOD LEAK TEST STRIPSReprocessing Products Corp2013-03-20990
K101750RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-ZReprocessing Products Corp2011-01-071990
K090338ULTRA LOW TOTAL CHLORINE, E-Z CHEK SENSITIVE TOTAL CHLORINEReprocessing Products Corp2009-05-08870
K974426POTENCY TEST STRIPS, INDICATOR TEST STRIPSReprocessing Products Corp1999-02-104710
K974064MICRO X RESIDUAL TEST STRIPSReprocessing Products Corp1998-12-074060
K950602PORT CAPS (PROTECTIVE CLOSURES FOE REPROCESSED HEMODIALYZERSReprocessing Products Corp1995-11-302940

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda