Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NQL · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
244 daysmedian FDA review time
288 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K193103 | NeoBase 2 Non-derivatized MSMS Kit | Perkinelmer, Inc. | 2020-02-07 | 91 | 0 |
| K173568 | NeoBase 2 Non-derivatized MSMS Kit | Wallac Oy, Subsidiary of Perkinelmer, Inc. | 2018-09-04 | 288 | 0 |
| K093916 | NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001U | Perkinelmer, Inc. | 2010-08-23 | 244 | 0 |
| K083130 | NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040 | Perkinelmer, Inc. | 2009-07-09 | 259 | 1 |
| DEN040002 | NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROME | Perkinelmer Life Sciences, Inc. | 2004-08-24 | 53 | 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