510(k) Report

510(k) · Cleared

Recalled · 2009

Whatman Body Fluid Collection Paper:Whatman BFC180

K932661510(k) TraditionalCleared Apr 17, 19961,050-day reviewClass II21 CFR 862.1675Recalls 3

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Whatman Specialty Products, Inc. · PJC Newborn Screening Specimen Collection Paper

Cleared on Apr 17, 1996 after a 1,050-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it. It has been recalled 3 times.

Decided
Apr 17, 1996
Review
1,050 days
Class
Class II
Product code
PJC
Recalls
3
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2013: 1 descendant cleared1995200020052010201520202025
  1. This deviceK932661 Whatman Body Fluid Collection Paper:Whatman BFC180Whatman Specialty Products, Inc. · 1996
  2. Descendant · cites it directly · 1 of its ownK062932 Ahlstrom Grade 226 Specimen Collection PaperAhlstrom Mount Holly Springs, LLC · 2007
  3. Descendant · 2 generations on · 0 of its ownK121864 Perkinelmer 226 Sample Collection DevicesPerkinelmer, Inc. · 2013 · Recalled

Most influential descendants

Showing 2 of 2 · See all
  • K062932Ahlstrom Grade 226 Specimen Collection PaperAhlstrom Mount Holly Springs, LLC · 2007 · cites it directly1descendant
  • K121864Perkinelmer 226 Sample Collection DevicesPerkinelmer, Inc. · 2013 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K932661Whatman Body Fluid Collection Paper:Whatman BFC180Whatman Specialty Products, Inc.1996—
+1K062932Ahlstrom Grade 226 Specimen Collection PaperAhlstrom Mount Holly Springs, LLC2007—
+2K121864Perkinelmer 226 Sample Collection DevicesPerkinelmer, Inc.20133

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201310
FIG. 1 — Lineage of K932661, 1996–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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
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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K062932Ahlstrom Grade 226 Specimen Collection PaperAhlstrom Mount Holly Springs, LLC20071

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 29, 2009Not classifiedZ-2384-2010Process controlNeonate newborn screening card demographic and filter portion may be detached
May 19, 2009Not classifiedZ-1005-2010Process control'903' newborn Neonate screening cards have duplicate numbers assigned on cards and may result in cross-over of patient test results
May 6, 2009Not classifiedZ-1871-2009Process controlThe two portions of the card are coming apart prematurely.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K062932 (Ahlstrom Mount Holly Springs, LLC, 2007) has gone furthest, with 1 descendant of its own.

How does its category compare?

All PJC devices

PJC Newborn Screening Specimen Collection Paper: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · PJC

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20131—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

Recent decisions in PJC

The PJC category page

  • K121864Perkinelmer 226 Sample Collection DevicesPerkinelmer, Inc. · 20133 recalls

https://510kreport.com/device/K932661 · printed Nov 6, 2026

Cite this page

510(k) Report. “K932661: Whatman Body Fluid Collection Paper:Whatman BFC180.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K932661

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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