510(k) Report

510(k) · Cleared

Cleared

Onguard 1000, Catalog #043611-000 & 043611-001

K870976510(k) TraditionalCleared May 6, 198757-day reviewClass II21 CFR 870.4220

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

Cobe Laboratories, Inc. · DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass

Cleared on May 6, 1987 after a 57-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
May 6, 1987
Review
57 days
Class
Class II
Product code
DTQ
Recalls
None
Predicates
0

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

Descendants, by year cleared 1998: 1 descendant cleared1990200020102020
  1. This deviceK870976 Onguard 1000, Catalog #043611-000 & 043611-001Cobe Laboratories, Inc. · 1987
  2. Descendant · cites it directly · 0 of its ownK981412 M1145 (UPS1-1.25K-1G-MP) UpsClary Corp. · 1998

Most influential descendants

Showing 1 of 1 · See all
  • K981412M1145 (UPS1-1.25K-1G-MP) UpsClary Corp. · 1998 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K870976Onguard 1000, Catalog #043611-000 & 043611-001Cobe Laboratories, Inc.1987—
+1K981412M1145 (UPS1-1.25K-1G-MP) UpsClary Corp.1998—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
FIG. 1 — Lineage of K870976, 1987–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 DTQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DTQ device

  1. #1 K221373 Essenz HLMscore 8.9 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, 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
K981412M1145 (UPS1-1.25K-1G-MP) UpsClary Corp.19980

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K981412 (Clary Corp., 1998) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DTQ devices

DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DTQ

3in 2023

2007: 22008: 12009: 32010: 12011: 22014: 22015: 22017: 22018: 12019: 12021: 22023: 3
2007high 3 (2009) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTQ

292in 2023

2009: 86 days median2023: 292 days median
2007high 292 (2023) · low 86 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DTQ

1in 2024

2007: 92008: 172009: 12010: 172011: 222012: 422013: 42014: 12018: 12019: 1, 1 Class I2022: 12023: 7, 1 Class I2024: 1
2007high 42 (2012) · low 0 (2015)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · DTQ

1,014in 2025

2007: 4202008: 5482009: 5892010: 8112011: 1,0812012: 1,6262013: 9062014: 1,2902015: 1,1842016: 7142017: 5272018: 6762019: 8572020: 6272021: 7292022: 7172023: 8182024: 8632025: 1,014
2007high 1,626 (2012) · low 420 (2007)2025

MAUDE reports naming product code DTQ, 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
20072—9420
20081—17548
20093861589
20101—17811
20112—221,081
20120—421,626
20130—4906
20142—11,290
20152—01,184
20160—0714
20172—0527
20181—1676
20191—1 (1)857
20200—0627
20212—0729
20220—1717
202332927 (1)818
20240—1863
20250—01,014
20260—0—

More from Cobe Laboratories, Inc.

77 FDA decisions under this applicant name. See the company

  • K923272Cobe CMS-HF Hollow Fiber Membrane OxygenatorCobe Laboratories, Inc. · 1993
  • K900105Cobe Spectra Blood Component Separator TherapeuticCobe Laboratories, Inc. · 1991
  • K905793Cobe Centry 2 Bicart Option KitCobe Laboratories, Inc. · 1991
  • K905388Cobe Centrysystem 3 Bicart Option KitCobe Laboratories, Inc. · 1991
  • K904336New Cobe Saturation/Hematocrit MonitorCobe Laboratories, Inc. · 1990

Recent decisions in DTQ

The DTQ category page

  • K232291Essenz HLM, Essenz ILBMLivanova Deutschland, GmbH · 20231 recall
  • K221895Terumo Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation · 2023
  • K221373Essenz HLMLivanova Deutschland, GmbH · 2023
  • K210130Stockert S5 SystemLivanova Deutschland, GmbH · 2021
  • K202125Century Perfusion SystemCentury Hlm, LLC · 2021

https://510kreport.com/device/K870976 · printed Nov 4, 2026

Cite this page

510(k) Report. “K870976: Onguard 1000, Catalog #043611-000 & 043611-001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K870976

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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