Perkinelmer, Inc.: FDA clearances and approvals
Perkinelmer, Inc. has 15 FDA 510(k) clearances (first 2009, latest 2022), plus 2 De Novo decisions, across 11 product codes in 4 review panels. Median 510(k) review time: 150 days. Since 2017 its median was 178 days, against 40 days for all cleared 510(k)s in the same product codes. openFDA lists 22 product recalls by a recalling firm named Perkinelmer, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 104 |
| 2013 | 1 | 259 |
| 2014 | 2 | 90 |
| 2015 | 0 | — |
| 2016 | 2 | 50 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 2 | 174 |
| 2020 | 1 | 91 |
| 2021 | 0 | — |
| 2022 | 1 | 765 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Perkinelmer, Inc.'s cleared 510(k)s took a median 178 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 40 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 5 | 5 |
| NQL | System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry | 3 | 3 |
| JIA | Enzymatic Methods, Galactose | 1 | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 | 1 |
| KQP | Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase | 1 | 1 |
| NAK | System, Test, Biotinidase | 1 | 1 |
| PJC | Newborn Screening Specimen Collection Paper | 1 | 1 |
| PJI | Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System | 1 | 1 |
| PQW | Alpha-D-Galactosidase A (Gla) Newborn Screening Test System | 1 | 1 |
| QJE | Muscular Dystrophy Newborn Screening Test | 1 | 0 |
Plus 1 more product codes.
Review panels
- Clinical Chemistry (10)
- Radiology (5)
- Immunology (1)
- Medical Genetics (1)
Most recent Perkinelmer, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K203035 | Eonis SCID-SMA kit | PJI | 2022-11-09 | 765 |
| K193103 | NeoBase 2 Non-derivatized MSMS Kit | NQL | 2020-02-07 | 91 |
| K190335 | GSP Neonatal Total Galactose kit | JIA | 2019-11-06 | 265 |
| K190266 | NeoLSD MSMS Kit | PQW | 2019-05-03 | 84 |
| K161966 | PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector | MQB | 2016-09-08 | 52 |
| K161942 | PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector | MQB | 2016-09-01 | 48 |
| K142698 | PerkinElmer, XRpad 4343 F MED Flat Panel Detector | MQB | 2014-10-23 | 31 |
| K140551 | PERKINELMER, XRPAD 4336 MED FLAT PANEL DETECTOR | MQB | 2014-08-01 | 150 |
| K121864 | PERKINELMER 226 SAMPLE COLLECTION DEVICES | PJC | 2013-03-12 | 259 |
| K122495 | PERKINELMER XRD 1622 AP3 MED FLAT PANEL DETECTOR | MQB | 2012-11-28 | 104 |
5 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN200044 | De Novo | Spinal Muscular Atrophy Newborn Screening Test System | 2022-11-09 |
| DEN180056 | De Novo | Muscular Dystrophy Newborn Screening Test | 2019-12-12 |
Recalls
22 product recalls in 6 recall events; 0 initiated in the last five years. Most recent: 2016-10-13.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Perkinelmer, Inc. have?
Perkinelmer, Inc. has 15 FDA 510(k) clearances (first 2009, latest 2022), plus 2 De Novo decisions, across 11 product codes in 4 review panels.
How long does FDA take to clear Perkinelmer, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Perkinelmer, Inc.'s cleared 510(k)s is 150 days. Since 2017: 178 days, versus 40 days for all cleared 510(k)s in the same product codes.
What devices does Perkinelmer, Inc. make?
Its most frequent FDA product codes are MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager), 5); NQL (System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry, 3); JIA (Enzymatic Methods, Galactose, 1).
Has Perkinelmer, Inc. had device recalls?
openFDA lists 22 product recalls in 6 recall events by a recalling firm whose name matches Perkinelmer, Inc; the most recent began 2016-10-13. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 15 Perkinelmer, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MQB, Perkinelmer, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.