Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JIN — Predicate Candidate Screening
24 FDA 510(k) clearances under this product code; the 50 most recent screened below.
117 daysmedian FDA review time
310 days90th percentile
24clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K201551 | KetoSens BT Blood B-Ketone Monitoring System | I-Sens, Inc. | 2020-09-09 | 92 | 0 |
| K192957 | VivaChek Blood Glucose and B-Ketone Monitoring System | Vivachek Biotech (Hangzhou) Co., Ltd. | 2020-06-05 | 228 | 0 |
| K182593 | KET-1 Blood Ketone Monitoring System | Apex BioTechnology Corp. | 2018-12-18 | 89 | 0 |
| K173345 | TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring | Taidoc Technology Corporation | 2018-05-04 | 192 | 0 |
| K170463 | KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Bl | I-Sens, Inc. | 2018-04-13 | 422 | 0 |
| K170587 | On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ket | ACON Laboratories, Inc. | 2017-07-06 | 128 | 0 |
| K060768 | PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KE | Abbott Diabetes Care, Inc. | 2006-04-21 | 30 | 1 |
| K033114 | KETOCHECKS | Neo Diagnostics, Inc. | 2004-04-26 | 209 | 0 |
| K003987 | URS-1K (KETONE TESST) | Teco Diagnostics | 2001-04-26 | 121 | 0 |
| K953662 | FIRST CHOICE KETONES URINE TEST STRIPS | Polymer Technology Intl. | 1996-06-14 | 312 | 0 |
| K953680 | FIRST CHOICE GLUCOSE & KETONES URINE TEST STRIPS | Polymer Technology Intl. | 1996-06-12 | 310 | 0 |
| K911801 | KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON | Gds Technology, LLC | 1991-07-01 | 69 | 0 |
| K912373 | KETO-340 II | Ihara Medics U.S., Inc. | 1991-07-01 | 33 | 0 |
| K910108 | GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED | Gds Diagnostics | 1991-03-04 | 53 | 0 |
| K903365 | KETOREX SANWA STANDARDS | Ihara Medics U.S., Inc. | 1990-12-20 | 147 | 0 |
| K903367 | KETONE TEST A SANWA STANDARD | Ihara Medics U.S., Inc. | 1990-11-20 | 117 | 0 |
| K903366 | KETONE TEST B SANWA STANDARD | Ihara Medics U.S., Inc. | 1990-11-20 | 117 | 0 |
| K875029 | ABBOTT BREATH ACETONE ANALYZER | Abbott Laboratories | 1988-05-27 | 172 | 0 |
| K850368 | SIGMS B-HYDROXYBUTARATE PROCEDURE NO. 310-UV | Sigma Chemical Co. | 1985-08-30 | 211 | 0 |
| K841715 | KYOTEST UK URINE TEST REAGENT STRIP | Kyoto Diagnostics, Inc. | 1984-05-31 | 37 | 0 |
| K831499 | GLUCOSE 3, INLAB REAGENT STRIPS-URINALY | Laprol Scientific, Inc. | 1983-06-17 | 37 | 0 |
| K830976 | HELENA BIOSTRIP K | Helena Laboratories | 1983-05-04 | 36 | 0 |
| K830975 | PLAN A LIFE | New Directions Co. | 1983-05-04 | 40 | 0 |
| K801270 | TEST FOR KETONE IN URINE(ACETOACETIC AC | Miles Laboratories, Inc. | 1980-07-08 | 41 | 0 |
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