510(k) Report

510(k) · Cleared

Recalled · 2006

Wilson-Cook Colon Decompression Set

K900035510(k) TraditionalCleared Mar 7, 199064-day reviewClass II21 CFR 876.5980Recalls 2

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

Wilson-Cook Medical, Inc. · FEG Tube, Double Lumen For Intestinal Decompression And/Or Intubation

Cleared on Mar 7, 1990 after a 64-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled 2 times.

Decided
Mar 7, 1990
Review
64 days
Class
Class II
Product code
FEG
Recalls
2
Predicates
0

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

Descendants, by year cleared 2017: 1 descendant cleared1990200020102020
  1. This deviceK900035 Wilson-Cook Colon Decompression SetWilson-Cook Medical, Inc. · 1990
  2. Descendant · cites it directly · 0 of its ownK171619 14Fr Colon Decompression Set, Macon Colon Decompression SetCook Ireland, Ltd. · 2017

Most influential descendants

Showing 1 of 1 · See all
  • K17161914Fr Colon Decompression Set, Macon Colon Decompression SetCook Ireland, Ltd. · 2017 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K900035Wilson-Cook Colon Decompression SetWilson-Cook Medical, Inc.1990—
+1K17161914Fr Colon Decompression Set, Macon Colon Decompression SetCook Ireland, Ltd.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
FIG. 1 — Lineage of K900035, 1990–2017Source: 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 FEG? 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 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
K17161914Fr Colon Decompression Set, Macon Colon Decompression SetCook Ireland, Ltd.20170

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

Recalls of this device

DateClassRecallRoot causeReason
Apr 3, 2006Not classifiedZ-0056-2007OtherThe firm failed to include User Instructions with the Stic Kit Needle Containment Device, Model EMI 82691, which they shipped to distributor/customers.
Oct 8, 2003Not classifiedZ-0048-04OtherProduct may be packaged with an incorrect instructions for use (IFU) booklet.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K171619 (Cook Ireland, Ltd., 2017) has gone furthest, with 0 descendants of its own.

How does its category compare?

All FEG devices

FEG Tube, Double Lumen For Intestinal Decompression And/Or Intubation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FEG

1in 2017

2013: 12017: 1
2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FEG

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

Recalls per year · FEG

2in 2025

2023: 102025: 2
2007high 10 (2023) · low 0 (2007)2026

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

Adverse event reports per year · FEG

46in 2025

2008: 12009: 32010: 12012: 22013: 22014: 52015: 12016: 42017: 132018: 152019: 362020: 232021: 272022: 402023: 332024: 312025: 46
2007high 46 (2025) · low 0 (2007)2025

MAUDE reports naming product code FEG, 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—01
20090—03
20100—01
20110—00
20120—02
20131—02
20140—05
20150—01
20160—04
20171—013
20180—015
20190—036
20200—023
20210—027
20220—040
20230—1033
20240—031
20250—246
20260—0—

More from Wilson-Cook Medical, Inc.

125 FDA decisions under this applicant name. See the company

  • K253302Hemospray Endoscopic Hemostat (HEMO-[X])Wilson-Cook Medical, Inc. · 20261 recall
  • K243568Teslatome Bipolar Sphincterotome; Tesla BiCord Active CordWilson-Cook Medical, Inc. · 20251 recall
  • K213356Entuit PEG, Entuit PEGJWilson-Cook Medical, Inc. · 2022
  • K212323Instinct Plus Endoscopic Clipping DeviceWilson-Cook Medical, Inc. · 20211 recall
  • K201322Entuit Nasal Jejunal Feeding TubeWilson-Cook Medical, Inc. · 2020

Recent decisions in FEG

The FEG category page

  • K17161914Fr Colon Decompression Set, Macon Colon Decompression SetCook Ireland, Ltd. · 2017
  • K132314Medline Anti-Reflux ValveMedline Industries, Inc. · 2013
  • K053410Gientriport with Universal Single Lumen AdaptorKendall · 2006
  • K040388Next Generation Salem SumpKendall · 2004
  • K971354Knott NG TubeMichael M. Knott, M.D. · 1997

https://510kreport.com/device/K900035 · printed Nov 6, 2026

Cite this page

510(k) Report. “K900035: Wilson-Cook Colon Decompression Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K900035

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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