Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KHP — Predicate Candidate Screening
27 FDA 510(k) clearances under this product code; the 50 most recent screened below.
76 daysmedian FDA review time
231 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K130113 | PICCOLO LACTATE TEST SYSTEM | Abaxis, Inc. | 2013-03-11 | 54 | 0 |
| K113216 | RAPIDPOINT 500 BLOOD GAS ANALYER | Siemens Healthcare Diagnostics | 2012-05-03 | 184 | 10 |
| K112955 | NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM | Nova Biomedical Corporation | 2012-01-05 | 93 | 0 |
| K112430 | I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE | Abbott Pont of Care, Inc. | 2011-12-20 | 118 | 0 |
| K100602 | NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTAT | Nova Biomedical Corp. | 2011-08-17 | 532 | 0 |
| K093297 | EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY | Epocal, Inc. | 2010-06-09 | 231 | 1 |
| K013938 | IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE | Diametrics Medical, Inc. | 2002-01-28 | 61 | 0 |
| K011478 | I-STAT SYSTEM | I-Stat Corp. | 2001-07-02 | 49 | 0 |
| K980908 | LACTATE PRO SYSTEM | Kdk Corp. | 1998-09-11 | 185 | 0 |
| K982071 | I-STAT LACTATE TEST | I-Stat Corp. | 1998-06-29 | 17 | 1 |
| K971944 | LACTEST I | Jwt, Inc. | 1997-12-17 | 204 | 0 |
| K951331 | ACCUSPORT LACTATE MONITORING SYSTEM LACTATE TEST STRIPS ACCU | Boehringer Mannheim Corp. | 1995-08-11 | 140 | 0 |
| K936066 | STAT PROFILE PLUS 9 ANALYZER | Nova Biomedical Corp. | 1995-03-09 | 443 | 0 |
| K934271 | BECKMAN SYNCHRON LACTATE REAGENT | Beckman-Diagnostic Systems Group | 1993-11-09 | 70 | 0 |
| K914508 | DIMENSION(R) LACTIC ACID METHOD | E.I. Dupont DE Nemours & Co., Inc. | 1991-11-27 | 49 | 0 |
| K913197 | KODAK EKTACHEM DT SLIDES (LAC) | Eastman Kodak Company | 1991-08-26 | 39 | 0 |
| K913330 | URINE COLLECTION KIT/DEVICE | Medical Implements, Inc. | 1991-08-26 | 32 | 0 |
| K910534 | SYNCHRON LACTATE REAGENT | Beckman Instruments, Inc. | 1991-04-08 | 59 | 0 |
| K901131 | YSI MODEL 1500 SPORT L-LACTATE ANALYZER | Yellow Springs Instrument Co., Inc. | 1990-08-27 | 168 | 0 |
| K897147 | SIGMA PROCEDURE NO. 735 | Sigma Diagnostics, Inc. | 1990-04-03 | 98 | 0 |
| K884189 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LAC) | Eastman Kodak Company | 1989-01-11 | 98 | 0 |
| K880787 | EASY-TEST LACTIC ACID (LA) | Diagnostic Systems | 1988-03-15 | 18 | 0 |
| K861741 | TDX REA LACTIC ACID | Abbott Laboratories | 1986-07-07 | 62 | 0 |
| K852261 | YSI MODEL 2372 TOTAL BLOOD LACTATE KIT | Yellow Springs Instrument Co., Inc. | 1985-08-15 | 83 | 0 |
| K840778 | LACTATE REAGENT | American Dade | 1984-04-13 | 65 | 0 |
| K802064 | DUPONT ACALACTIC ACID (LA) TEST | E.I. Dupont DE Nemours & Co., Inc. | 1980-09-26 | 30 | 0 |
| K790421 | ROCHE LACTATE ANALYZER 640 | Roche Medical Electronics, Inc. | 1979-05-15 | 76 | 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