Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
JJC — Predicate Candidate Screening
32 FDA 510(k) clearances under this product code; the 50 most recent screened below.
58 daysmedian FDA review time
113 days90th percentile
32clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K945915 | AVL OMNI ANALYZER | Avl Scientific Corp. | 1995-04-05 | 124 | 9 |
| K945584 | NOVA 16 ANALYZER | Nova Biomedical Corp. | 1995-02-08 | 86 | 0 |
| K943376 | OPERA SYSTEM | Miles, Inc. | 1994-09-14 | 63 | 0 |
| K901410 | TECHNICON RA-2000(TM) SYSTEM | Technicon Instruments Corp. | 1990-07-17 | 113 | 0 |
| K901141 | PARAMAX 520, PARAMAX 720 AND PARAMAX 720ZX | Baxter Healthcare Corp | 1990-04-09 | 27 | 0 |
| K890332 | RFA/2 RAPID FLOW ANALYZER W/COMPUTER | Alpkem Corp. | 1989-02-17 | 25 | 0 |
| K881056 | AMRESCO FLOW PAC RANDOM ACCESS LIQUID #4901030 | American Research Products Co. | 1988-11-15 | 249 | 0 |
| K875105 | TECHNICON SMAC 3 SYSTEM | Technicon Instruments Corp. | 1988-02-16 | 64 | 0 |
| K870998 | TECHNICON RA-XT(TM) SYSTEM IMMUNOASSAYS | Technicon Instruments Corp. | 1987-05-26 | 76 | 0 |
| K862561 | TECHNICON RA-XT SYSTEM WITH ANALYTES | Technicon Instruments Corp. | 1986-10-20 | 109 | 0 |
| K854345 | TECHNICON RA-500 SYSTEM | Technicon Instruments Corp. | 1985-11-26 | 29 | 0 |
| K852306 | REPLACEMENT REAGENTS FOR SMAC II SYSTEMS | Methodist Hospital of Memphis | 1985-08-02 | 65 | 0 |
| K833157 | LANCER ANALYZER CUPS | Sherwood Medical Co. | 1983-12-08 | 83 | 0 |
| K833023 | TECHNICON RA-1000 SYSTEM | Technicon Instruments Corp. | 1983-11-03 | 58 | 0 |
| K823233 | SBA 300 CLINICAL CHEMISTRY ANALYZER | Gilford Instrument Laboratories, Inc. | 1982-11-29 | 31 | 0 |
| K813077 | TECHNICON RA 1000 SYSTEM | Technicon Corp. | 1981-11-16 | 14 | 0 |
| K811249 | TECHNICON SMAC II SYSTEM & ACCESSORIES | Technicon Instruments Corp. | 1981-05-21 | 16 | 0 |
| K810394 | PRE-VAP CAPS | Sherman Boosalis | 1981-03-06 | 16 | 0 |
| K801481 | BMC RIAFLO SYSTEM | Boehringer Mannheim Corp. | 1980-08-20 | 57 | 0 |
| K800587 | NSI WASH SOLUTION CONCENTRATE | Nobel Scientific Industries, Inc. | 1980-08-08 | 144 | 0 |
| K800453 | PHOTOVOLT PVA 4M+2 ANALYZER | Photovolt Corp. | 1980-03-20 | 20 | 0 |
| K792285 | TECHNICON C800 SYSTEM | Technicon Instruments Corp. | 1979-12-06 | 23 | 0 |
| K781503 | TECHNICON STAT/LYTE ISE ELECTROLYTE | Technicon Instruments Corp. | 1978-09-27 | 28 | 0 |
| K771662 | AUTOMATIC ANALYZER | Lachat Chemicals, Inc. | 1977-12-06 | 98 | 0 |
| K771336 | SMA II | Technicon Instruments Corp. | 1977-08-26 | 39 | 0 |
| K770506 | IN VITRO DIAGNOSTIC REAGENTS | Norwood Scientific Associates, Inc. | 1977-05-06 | 51 | 0 |
| K761342 | SMA MICROLYZER | Technicon Instruments Corp. | 1977-02-01 | 35 | 0 |
| K761086 | REAGENTS | Simmler & Son, Inc. | 1977-01-12 | 58 | 0 |
| K760749 | SYSTEM 5 - SEMI-AUTOMATED CLIN. ANALY | Gilford Instrument Laboratories, Inc. | 1976-12-29 | 90 | 0 |
| K761165 | MT II - TEST FOR CONTINUOUS FLOW ANAL | Technicon Instruments Corp. | 1976-12-13 | 12 | 0 |
| K760622 | LANCER AUTOANALYZER MANIFOLD PUMP TUB | Sherwood Medical Industries | 1976-11-24 | 72 | 0 |
| K760211 | ANALYZER, GLUCOSE/UREA/CREATININE | Instrumentation Laboratory CO | 1976-08-26 | 45 | 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