510(k) Report

510(k) · Cleared

Recalled · 2008

Atriums PDR Thoracic Catheter

K912645510(k) TraditionalCleared Sep 13, 199188-day reviewClass I21 CFR 878.4200Recalls 17

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

Atrium Medical Corp. · GBS Catheter, Ventricular, General & Plastic Surgery

Cleared on Sep 13, 1991 after an 88-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it. It has been recalled 17 times.

Decided
Sep 13, 1991
Review
88 days
Class
Class I
Product code
GBS
Recalls
17
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared1990200020102020
  1. This deviceK912645 Atriums PDR Thoracic CatheterAtrium Medical Corp. · 1991
  2. Descendant · cites it directly · 0 of its ownK973472 3M Cdi H/S Cuvettes with Heparon Treatment3M Healthcare · 1997

Most influential descendants

Showing 1 of 1 · See all
  • K9734723M Cdi H/S Cuvettes with Heparon Treatment3M Healthcare · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K912645Atriums PDR Thoracic CatheterAtrium Medical Corp.1991—
+1K9734723M Cdi H/S Cuvettes with Heparon Treatment3M Healthcare1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
FIG. 1 — Lineage of K912645, 1991–1997Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GBS? 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K9734723M Cdi H/S Cuvettes with Heparon Treatment3M Healthcare19970

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

Recalls of this device

DateClassRecallRoot causeReason
May 12, 2008Not classifiedZ-1831-2008Nonconforming Material/ComponentHeparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
May 12, 2008Not classifiedZ-1839-2008Nonconforming Material/ComponentHeparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
May 12, 2008Not classifiedZ-1837-2008Nonconforming Material/ComponentHeparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
May 12, 2008Not classifiedZ-1842-2008Nonconforming Material/ComponentHeparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
May 12, 2008Not classifiedZ-1838-2008Nonconforming Material/ComponentHeparin-coated Thoracic Catheters were manufactured with heparinc allegedly contaminated with oversulfated chondroitin sulfate
May 12, 2008Not classifiedZ-1843-2008Nonconforming Material/ComponentHeparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
May 12, 2008Not classifiedZ-1844-2008Nonconforming Material/ComponentHeparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
May 12, 2008Not classifiedZ-1833-2008Nonconforming Material/ComponentHeparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
May 12, 2008Not classifiedZ-1841-2008Nonconforming Material/ComponentHeparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
May 12, 2008Not classifiedZ-1830-2008Nonconforming Material/ComponentHeparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
May 12, 2008Not classifiedZ-1834-2008Nonconforming Material/ComponentHeparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
May 12, 2008Not classifiedZ-1845-2008Nonconforming Material/ComponentHeparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
May 12, 2008Not classifiedZ-1836-2008Nonconforming Material/ComponentHeparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
May 12, 2008Not classifiedZ-1835-2008Nonconforming Material/ComponentHeparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
May 12, 2008Not classifiedZ-1846-2008Nonconforming Material/ComponentHeparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
May 12, 2008Not classifiedZ-1832-2008Nonconforming Material/ComponentHeparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
May 12, 2008Not classifiedZ-1840-2008Nonconforming Material/ComponentHeparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate

The 5 latest of 17 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K973472 (3M Healthcare, 1997) has gone furthest, with 0 descendants of its own.

How does its category compare?

All GBS devices

GBS Catheter, Ventricular, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GBS

FDA has decided no GBS device since 2007.

Median 510(k) review, days · GBS

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

Recalls per year · GBS

2in 2010

2008: 172009: 12010: 2
2007high 17 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GBS

1in 2025

2007: 22009: 12010: 12011: 12012: 12013: 12014: 22016: 22017: 42018: 22019: 12020: 12021: 22023: 22024: 22025: 1
2007high 4 (2017) · low 0 (2008)2025

MAUDE reports naming product code GBS, 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—02
20080—170
20090—11
20100—21
20110—01
20120—01
20130—01
20140—02
20150—00
20160—02
20170—04
20180—02
20190—01
20200—01
20210—02
20220—00
20230—02
20240—02
20250—01
20260—0—

More from Atrium Medical Corp.

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  • P120003/S006iCast Covered Stent SystemAtrium Medical Corp. · 2025

Recent decisions in GBS

The GBS category page

  • K883887Axiom Atraum Wound DrainsAxiom, Inc. · 1989
  • K881873Introduction/Drainage Catheter & AccessSheridan Catheter Corp. · 1988
  • K880895Uresil Wound Drain TrocarUresil Corp. · 1988
  • K880376Novo Vivo Suction Catheter Vessel W/Mucose TrapGenesis Industries, Inc. · 1988
  • K873377Closed Chest Drainage Set W/SuturesGish Biomedical, Inc. · 1987

https://510kreport.com/device/K912645 · printed Nov 6, 2026

Cite this page

510(k) Report. “K912645: Atriums PDR Thoracic Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K912645

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026