510(k) Report

FDA applicant

Perkinelmer, Inc.

Waltham, MA17 decisions2009–202210 recalls

FDA records 17 decisions for Perkinelmer, Inc. (Waltham, MA) from 2009 to 2022: 15 510(k) clearances and 2 De Novo grants. Most are in product codes MQB (Solid State X-Ray Imager (Flat Panel/Digital…) and NQL (System, Test, Amino Acids, Free Carnitines And…). Its devices cite 16 predicates, 5 of them its own earlier devices. 10 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Perkinelmer, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2022

2009: 22010: 32012: 12013: 12014: 22016: 22019: 32020: 12022: 2
2009high 3 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2026

2011: 12012: 32013: 12017: 42026 (partial year): 1
2009high 4 (2017) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Perkinelmer, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Perkinelmer, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)5decisions
  • NQLSystem, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry3decisions
  • NAKSystem, Test, Biotinidase1decision
  • JLWRadioimmunoassay, Thyroid-Stimulating Hormone1decision
  • PJISevere Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System1decision
  • PJCNewborn Screening Specimen Collection Paper1decision

Also: QJE (1), QUE (1), KQP (1), PQW (1), JIA (1).

Whose devices does it build on?

Its devices cite 16 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 12 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K140551Perkinelmer, Xrpad 4336 Med Flat Panel DetectorPerkinelmer, Inc. · 20145cite it
  • K090123Neonatal Biotinidase Kit, Model 3018Perkinelmer, Inc. · 20101cites it
  • K093916Neobase Non-Derivatized MSMS Kit Model 3040-001UPerkinelmer, Inc. · 20101cites it
  • K142698PerkinElmer, XRpad 4343 F MED Flat Panel DetectorPerkinelmer, Inc. · 20141cites it
  • DEN200044Eonis SCID-SMA KitPerkinelmer, Inc. · 20221cites it
  • K161966PerkinElmer XRpad2 4336 HWC-M Flat Panel DetectorPerkinelmer, Inc. · 20161cites it

What has FDA decided for it lately?

  • K203035Eonis SCID-SMA kitPerkinelmer, Inc. · 2022
  • DEN200044Eonis SCID-SMA KitPerkinelmer, Inc. · 2022
  • K193103NeoBase 2 Non-derivatized MSMS KitPerkinelmer, Inc. · 2020
  • DEN180056GSP Neonatal Creatine Kinase - MM kitPerkinelmer, Inc. · 2019
  • K190335GSP Neonatal Total Galactose kitPerkinelmer, Inc. · 2019
  • K190266NeoLSD MSMS KitPerkinelmer, Inc. · 2019
  • K161966PerkinElmer XRpad2 4336 HWC-M Flat Panel DetectorPerkinelmer, Inc. · 2016
  • K161942PerkinElmer, XRpad2 3025 HWC-M Flat Panel DetectorPerkinelmer, Inc. · 2016

All 17 as Perkinelmer, Inc. →

What has been recalled?

10 recalls linked to its devices; the latest:

  • K100101GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in…May 18, 2026Class II
  • K121864PerkinElmer 226 Sample Collection DeviceDec 19, 2017Class III
  • K083130NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers…Nov 2, 2017Class II
  • K121864PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection Device is…May 31, 2017Class III
  • K090846Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Intended for in…Jan 5, 2017Class II
  • K121864Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The…Sep 5, 2013Class II

Other applicant names beginning “Perkinelmer”

FDA records each applicant name separately; these may or may not be the same firm.

Perkinelmer Life Sciences, Inc. 2Perkinelmer Optoelectronics 2