FDA applicant
Serim Research Corp.
FDA records 31 decisions for Serim Research Corp. (Elkhart, IN) from 1990 to 2026: 31 510(k) clearances. Most are in product codes JOJ (Indicator, Physical/Chemical Sterilization…) and LIF (Dialyzer Reprocessing System). Since 2016 its 510(k)s took a median of 89 days from receipt to decision, against 108 for FDA’s reviews in the same codes and years. Its devices cite 19 predicates, 8 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Serim Research”, “Serim Research Corporation”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Serim Research Corp.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Serim Research Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report