510(k) Report

FDA product code · Clinical chemistry

Capillary Blood Collection Device For Alternative Site Collection

PRJClass II21 CFR 862.1675510(k) required2 decisions since 20170 recalls

2 FDA decisions since 2017. No recall names this code. The most-cited predicate is K161521, named by 1 later device.

A capillary blood collection device with or without integrated micro-needles is a blood collection device intended to collect and/or transport capillary whole blood specimens for testing of clinical analytes.

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 PRJ 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 · PRJ

1in 2019

2017: 12019: 1
2007high 1 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PRJ

Too few PRJ 510(k)s in any year since 2007 to give a median.

Recalls per year · PRJ

No recall names PRJ since 2007.

Adverse event reports per year · PRJ

1in 2023

2023: 1
2007high 1 (2023) · low 0 (2007)2025

MAUDE reports naming product code PRJ, not matched to any one device; reports are not rates.

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
20130—00
20140—00
20150—00
20160—00
20171—00
20180—00
20191—00
20200—00
20210—00
20220—00
20230—01
20240—00
20250—00
20260—0—
FIG. 1 — PRJ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PRJ? 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 PRJ devices cite most?

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

  • K161521TAP Blood Collection DeviceSeventh Sense Biosystems, Inc. · 20171cites it

Which PRJ devices have the deepest lineage?

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

  • K190225TAP Blood Collection DeviceSeventh Sense Biosystems, Inc. · 20193generations
  • K161521TAP Blood Collection DeviceSeventh Sense Biosystems, Inc. · 20172generations

What has FDA decided in PRJ lately?

  • K190225TAP Blood Collection DeviceSeventh Sense Biosystems, Inc. · 2019
  • K161521TAP Blood Collection DeviceSeventh Sense Biosystems, Inc. · 2017

All 2 PRJ decisions →

Related product codes

Other codes under 21 CFR 862.1675.

PJE Blood/Plasma Collection Device For Dna TestingGJE Tray, Blood CollectionGIM Tubes, Vacuum Sample, With AnticoagulantQZG Menstrual Blood Collection DeviceJKA Tubes, Vials, Systems, Serum Separators, Blood…OYJ Dna Specimen Collection, SalivaPQD Blood Specimen Collection Convenience Kit…PJD Oral Fluid Drugs Of Abuse And Alcohol Test…PJC Newborn Screening Specimen Collection Paper