Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CHI — Predicate Candidate Screening
20 FDA 510(k) clearances under this product code; the 50 most recent screened below.
70 daysmedian FDA review time
238 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K970905 | SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT | Beckman Instruments, Inc. | 1997-06-04 | 84 | 1 |
| K961179 | SENTINEL LIPASE LIQUID MODEL 17.401B | Equal Diagnostics, Inc. | 1996-07-19 | 115 | 0 |
| K952180 | CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMS | Beckman Instruments, Inc. | 1995-08-17 | 100 | 0 |
| K952647 | IL TEST LIPASE | Instrumentation Laboratory CO | 1995-07-20 | 41 | 0 |
| K952816 | LIPASE FLEX REAGENT CARTRIDGE | Dupont Medical Products | 1995-07-20 | 30 | 1 |
| K941085 | LIPASE-PS ASSAY PROCEDURE NO. 805 | Sigma Diagnostics, Inc. | 1994-05-17 | 70 | 0 |
| K923917 | ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY | Nuclear Diagnostics, Inc. | 1994-02-25 | 569 | 0 |
| K921249 | WAKO AUTOKIT LIPASE-COLOR | Wako Chemicals USA, Inc. | 1992-07-21 | 127 | 0 |
| K920337 | MILES LIPASE SERA-PAK METHOD | Heraeus Kulzer, Inc. | 1992-03-11 | 47 | 0 |
| K900827 | COLORIMETRIC CHLORIDE PRODUCT #4314125 | American Research Products Co. | 1990-05-02 | 70 | 0 |
| K897150 | LIPASE COLOR [TOYO] SERUM LIPASE TEST KIT | Toyo Jozo Co., Ltd. | 1990-02-26 | 62 | 4 |
| K884596 | ABBOTT A-GENT LIPASE REAGENT | Abbott Laboratories | 1988-12-06 | 33 | 0 |
| K874027 | LIPASE UV [TOYO] | Advocacy International, Ltd. | 1988-05-27 | 238 | 0 |
| K875173 | KODAK EKTACHEM DT SLIDES (LIPA) | Eastman Kodak Company | 1988-02-24 | 69 | 0 |
| K874640 | WAKO(TM) AUTOKIT LIPASE | Wako Chemicals USA, Inc. | 1987-12-22 | 40 | 0 |
| K862312 | ENZLIPASE, ENZYMATIC LIPASE KIT | Nuclear Diagnostics, Inc. | 1986-09-26 | 100 | 0 |
| K845027 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES | Eastman Kodak Company | 1985-01-18 | 22 | 1 |
| K811553 | REAGENT SET TRIGLYCERIDES | Boehringer Mannheim Corp. | 1981-06-18 | 16 | 0 |
| K802842 | SINGLE VIAL LIPASE TEST KIT | Biodynamics Corp. | 1980-12-18 | 36 | 0 |
| K760786 | ENZYMATIC LIPASE MAX-PACK REAGENT | Calbiochem | 1977-01-06 | 92 | 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