510(k) Report

FDA product code · Clinical chemistry

Newborn Screening Specimen Collection Paper

PJCClass II21 CFR 862.1675510(k) required2 decisions since 19960 recalls

2 FDA decisions since 1996. No recall names this code. The most-cited predicate is K932661, named by 1 later device.

Newborn screening specimen collection paper is a blood collection device intended to be used as medium to collect and transport whole blood specimens from newborns to the laboratory for in vitro diagnostic analysis.

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

FIG. A — Illustration, clinical chemistry panel

Twenty years of PJC at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

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—
FIG. 1 — PJC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PJC? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do PJC devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K932661Whatman Body Fluid Collection Paper:Whatman BFC180Whatman Specialty Products, Inc. · 19961cites it

Which PJC devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K121864Perkinelmer 226 Sample Collection DevicesPerkinelmer, Inc. · 20132generations

What has FDA decided in PJC lately?

  • K121864Perkinelmer 226 Sample Collection DevicesPerkinelmer, Inc. · 20133 recalls
  • K932661Whatman Body Fluid Collection Paper:Whatman BFC180Whatman Specialty Products, Inc. · 19963 recalls

All 2 PJC decisions →

Related product codes

Other codes under 21 CFR 862.1675.

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