Serim Research Corp.: FDA clearances and approvals
Serim Research Corp. has 31 FDA 510(k) clearances (first 1990, latest 2026), across 12 product codes in 4 review panels. Median 510(k) review time: 104 days. Since 2017 its median was 96 days, against 90 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 224 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 2 | 149 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 61 |
| 2026 | 1 | 104 |
Review time against the same product codes
Since 2017, Serim Research Corp.'s cleared 510(k)s took a median 96 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JOJ | Indicator, Physical/Chemical Sterilization Process | 12 | 12 |
| LIF | Dialyzer Reprocessing System | 5 | 5 |
| FJD | Detector, Leak, Blood | 2 | 2 |
| FKJ | Filter, Blood, Dialysis | 2 | 2 |
| LYR | Helicobacter Pylori | 2 | 2 |
| MED | Sterilant, Medical Devices | 2 | 2 |
| FIP | Subsystem, Water Purification | 1 | 1 |
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 1 | 1 |
| LJX | Test, Urine Leukocyte | 1 | 1 |
| MNV | Strip, Dialysate Ph Indicator | 1 | 1 |
Plus 2 more product codes.
Review panels
- General Hospital (14)
- Gastroenterology and Urology (13)
- Microbiology (3)
- Hematology (1)
Most recent Serim Research Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253863 | GUARDIAN Quick Dip Residual Chlorine (5212) | FKJ | 2026-03-17 | 104 |
| K251035 | DISINTEK PA Test Strips | JOJ | 2025-06-03 | 61 |
| K202565 | WAVICIDE-OPA MEC Indicator | JOJ | 2020-12-02 | 89 |
| K192445 | QwikCheck Chemical Indicators | JOJ | 2020-04-02 | 209 |
| K120652 | RAPICIDE OPA-28 TEST STRIP | JOJ | 2012-10-12 | 224 |
| K092346 | SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171 | JOJ | 2010-01-07 | 156 |
| K083295 | SERIM DISINTEK GTA 2.1%, MODEL: 5164 | JOJ | 2009-03-16 | 126 |
| K082352 | SERIM DISINTEK OPA TEST STRIP | JOJ | 2008-09-25 | 40 |
| K081370 | SERIM DISINTEK OPA TEST STRIP | JOJ | 2008-07-11 | 57 |
| K080712 | SERIM HISENSE ULTRA 0.1, PART NUMBER 5167 | MSY | 2008-05-06 | 54 |
21 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Serim Research 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 Serim Research Corp. have?
Serim Research Corp. has 31 FDA 510(k) clearances (first 1990, latest 2026), across 12 product codes in 4 review panels.
How long does FDA take to clear Serim Research Corp.'s 510(k)s?
The median time from FDA receipt to decision across Serim Research Corp.'s cleared 510(k)s is 104 days. Since 2017: 96 days, versus 90 days for all cleared 510(k)s in the same product codes.
What devices does Serim Research Corp. make?
Its most frequent FDA product codes are JOJ (Indicator, Physical/Chemical Sterilization Process, 12); LIF (Dialyzer Reprocessing System, 5); FJD (Detector, Leak, Blood, 2).
Has Serim Research Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Serim Research Corp. Related entities may recall under other names.
Next steps
- See all 31 Serim Research Corp. clearances with predicates and recalls
- Run predicate analysis for product code JOJ, Serim Research 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.