Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Perkinelmer, Inc. · Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
157 daysmedian FDA review time
765 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K203035 | Eonis SCID-SMA kit | Perkinelmer, Inc. | 2022-11-09 | 765 | 0 |
| DEN200044 | Eonis SCID-SMA Kit | Perkinelmer, Inc. | 2022-11-09 | 854 | 0 |
| K193103 | NeoBase 2 Non-derivatized MSMS Kit | Perkinelmer, Inc. | 2020-02-07 | 91 | 0 |
| DEN180056 | GSP Neonatal Creatine Kinase - MM kit | Perkinelmer, Inc. | 2019-12-12 | 427 | 0 |
| K190335 | GSP Neonatal Total Galactose kit | Perkinelmer, Inc. | 2019-11-06 | 265 | 0 |
| K190266 | NeoLSD MSMS Kit | Perkinelmer, Inc. | 2019-05-03 | 84 | 0 |
| K161966 | PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector | Perkinelmer, Inc. | 2016-09-08 | 52 | 0 |
| K161942 | PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector | Perkinelmer, Inc. | 2016-09-01 | 48 | 0 |
| K142698 | PerkinElmer, XRpad 4343 F MED Flat Panel Detector | Perkinelmer, Inc. | 2014-10-23 | 31 | 0 |
| K140551 | PERKINELMER, XRPAD 4336 MED FLAT PANEL DETECTOR | Perkinelmer, Inc. | 2014-08-01 | 150 | 0 |
| K121864 | PERKINELMER 226 SAMPLE COLLECTION DEVICES | Perkinelmer, Inc. | 2013-03-12 | 259 | 2 |
| K122495 | PERKINELMER XRD 1622 AP3 MED FLAT PANEL DETECTOR | Perkinelmer, Inc. | 2012-11-28 | 104 | 0 |
| K093916 | NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001U | Perkinelmer, Inc. | 2010-08-23 | 244 | 0 |
| K100101 | GSP NEONATALGALT KIT, MODEL 3303-001U | Perkinelmer, Inc. | 2010-06-11 | 149 | 1 |
| K090123 | NEONATAL BIOTINIDASE KIT, MODEL 3018 | Perkinelmer, Inc. | 2010-03-05 | 408 | 0 |
| K090846 | GSP INSTRUMENT AND GSP NEONATAL HTSH KIT | Perkinelmer, Inc. | 2009-09-03 | 157 | 4 |
| K083130 | NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040 | Perkinelmer, Inc. | 2009-07-09 | 259 | 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