510(k) Report

510(k) · Decided

Decided

Quicvage Plus

K914908510(k) TraditionalDecided Apr 13, 1992164-day reviewClass II21 CFR 876.5980

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

Autovage · KDH Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration

Cleared on Apr 13, 1992 after a 164-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Apr 13, 1992
Review
164 days
Class
Class II
Product code
KDH
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K914908Source: FDA 510(k) database · 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 KDH? 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?

No later submission names this one as a predicate yet.

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.

How does its category compare?

All KDH devices

KDH Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KDH

FDA has decided no KDH device since 2007.

Median 510(k) review, days · KDH

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

Recalls per year · KDH

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

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

Adverse event reports per year · KDH

3in 2022

2007: 22010: 12017: 102019: 32022: 3
2007high 10 (2017) · low 0 (2008)2025

MAUDE reports naming product code KDH, 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—00
20090—00
20100—01
20110—00
20120—10
20130—00
20140—00
20150—00
20160—00
20170—010
20180—00
20190—03
20200—00
20210—00
20220—03
20230—00
20240—00
20250—00
20260—0—

More from Autovage

7 FDA decisions under this applicant name. See the company

Recent decisions in KDH

The KDH category page

  • K983624Giltech Plus Connecting Tube SetGiltech Plus, Inc. · 1999
  • K981286Superflow Irrigation and Aspiration Tubing SetsArmm, Inc. · 1998
  • K971259Combiport Fluid Lavage DeviceB.Braun Medical, Inc. · 1997
  • K962850Tum-E-VacEthox Corp. · 1997
  • K951533Easi-Lav Pediatric / Adult Gastric Lavage KitBallard Medical Products · 1995

https://510kreport.com/device/K914908 · printed Nov 4, 2026

Cite this page

510(k) Report. “K914908: Quicvage Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K914908

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