510(k) · Cleared
Recalled · Class II · 2017Perkinelmer 226 Sample Collection Devices
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Perkinelmer, Inc. · PJC Newborn Screening Specimen Collection Paper
Cleared on Mar 12, 2013 as substantially equivalent to K062932 (Ahlstrom Mount Holly Springs, LLC, 2007) after a 259-day review. Its family tree reaches back 2 generations to 1996. It has been recalled 3 times.
- Decided
- Mar 12, 2013
- Review
- 259 days
- Class
- Class II
- Product code
- PJC
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 2 generations to K932661 (1996). No later device cites it as a predicate yet.
- Root · 2 generations backK932661 Whatman Body Fluid Collection Paper:Whatman BFC180Whatman Specialty Products, Inc. · 1996 · Recalled
- 1 generation backK062932 Ahlstrom Grade 226 Specimen Collection PaperAhlstrom Mount Holly Springs, LLC · 2007
- This deviceK121864 Perkinelmer 226 Sample Collection DevicesPerkinelmer, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K932661 | Whatman Body Fluid Collection Paper:Whatman BFC180 | Whatman Specialty Products, Inc. | 1996 | 3 |
| −1 | K062932 | Ahlstrom Grade 226 Specimen Collection Paper | Ahlstrom Mount Holly Springs, LLC | 2007 | — |
| 0 (this device) | K121864 | Perkinelmer 226 Sample Collection Devices | Perkinelmer, Inc. | 2013 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PJC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K062932 | Ahlstrom Grade 226 Specimen Collection PaperSummary page 1…62.1675 Classification Name: tubes, vials, systems, serum separators, blodd collection Product Code: JKA Predicate Device(s): Ahlstrom 226 Specimen Collection Paper - K062932 Whatman 903 Specimen Collection Paper - pre-amendment device Device Description: PerkinElmer 226 Sample Collection Device is des… | 2007 |
| * | — | Whatman 903 Specimen Collection Paper Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 19, 2017 | Class III | Z-2264-2020 | Packaging process control | PerkinElmer 226 Sample Collection Devices Lot Number 40020001 had serial numbers printed on the pack labels that did not match the serial number range of the devices contained within the pack. |
| May 31, 2017 | Class III | Z-2756-2017 | Packaging | PerkinElmer 226 Sample Collection Devices Lot Number 317114 had serial numbers printed on the pack labels that did not match the serial number range of the devices contained within the pack. |
| Sep 5, 2013 | Class II | Z-0030-2014 | Material/Component Contamination | Some devices may be contaminated on the back side of the device with glue in the blood application area. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 11.5 years on median.
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All PJC devicesPJC Newborn Screening Specimen Collection Paper: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · PJC
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · PJC
Too few PJC 510(k)s in any year since 2007 to give a median.
Recalls per year · PJC
No recall names PJC since 2007.
Adverse event reports per year · PJC
No MAUDE report names PJC since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K121864 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121864: Perkinelmer 226 Sample Collection Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121864
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026