Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JNO · Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
130 daysmedian FDA review time
281 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K110274 | AUTODELFIA NEONATAL IRT KIT | Wallac Oy, A Subsidiary of Perkinelmer, Inc. | 2011-06-10 | 130 | 0 |
| K102419 | GSP NEONATAL IRT KIT (3306-001U) | Wallac Oy, Subsidiary of Perkinelmer | 2010-12-16 | 113 | 0 |
| K932406 | NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT | Nuclear Diagnostics, Inc. | 1993-12-02 | 203 | 0 |
| K883011 | MRI NEO-TRYP TRYPSIN RIA | Microbiological Research Corp. | 1989-04-26 | 281 | 0 |
| K861097 | TRYPSIN RIA KIT | Microanalytic Research, Inc. | 1986-05-29 | 66 | 0 |
| K811805 | TRYPIN (125I) RIA KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-08-31 | 68 | 0 |
| K791202 | RIA KIT FOR TRYPSIN | Cis Radiopharmaceuticals, Inc. | 1979-11-05 | 130 | 1 |
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