510(k) Report

510(k) · Cleared

Recalled · Class II · 2024

Chase Sucker

K971022510(k) TraditionalCleared Apr 17, 199728-day reviewClass II21 CFR 880.6740Recalls 1

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

Chase Medical, Inc. · GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered

Cleared on Apr 17, 1997 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled once.

Decided
Apr 17, 1997
Review
28 days
Class
Class II
Product code
GCX
Recalls
1
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K971022Source: 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 GCX? 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?

No later submission names this one as a predicate yet.

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

Recalls of this device

DateClassRecallRoot causeReason
Nov 19, 2024Class IIZ-0796-2025Process controlIncomplete or partial pouch seals, which may result in a breach in the sterility.

No ancestor or descendant has a Class I recall.

How does its category compare?

All GCX devices

GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GCX

FDA has decided no GCX device since 2007.

Median 510(k) review, days · GCX

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

Recalls per year · GCX

1in 2024

2013: 12017: 12023: 32024: 12026 (partial year): 3
2007high 3 (2023) · low 0 (2007)2026

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

Adverse event reports per year · GCX

274in 2025

2007: 242008: 442009: 402010: 512011: 672012: 2422013: 472014: 322015: 522016: 992017: 452018: 502019: 652020: 652021: 652022: 722023: 592024: 652025: 274
2007high 274 (2025) · low 24 (2007)2025

MAUDE reports naming product code GCX, 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—024
20080—044
20090—040
20100—051
20110—067
20120—0242
20130—147
20140—032
20150—052
20160—099
20170—145
20180—050
20190—065
20200—065
20210—065
20220—072
20230—359
20240—165
20250—0274
20260—3—

More from Chase Medical, Inc.

27 FDA decisions under this applicant name. See the company

  • K032531Chase Cardiac Analysis SystemChase Medical, Inc. · 2004
  • K022093Chase Cardiovascular Patch KitChase Medical, Inc. · 2002
  • K021129Chare Cariovascular PatchChase Medical, Inc. · 2002
  • K020233Chase Cardiovascular Patch KitChase Medical, Inc. · 2002
  • K020132Chase Cardiovascular Patch KitChase Medical, Inc. · 2002

Recent decisions in GCX

The GCX category page

  • K042454Stryker Cassette PumpStryker Endoscopy · 20045 recalls
  • K992126Circon Surgiflex Wave Tsunami Suction-Irrigation SystemCircon Corp. · 1999
  • K972074Suction InstrumentationWalter Lorenz Surgical, Inc. · 1997
  • K964127Medi-Vac Flexi-Clear Suction HandleAllegiance Healthcare Corp. · 1996
  • K964519Curity Thoracentesis TrayKendall Healthcare Products Co. Div.Of Tyco Health · 1996

https://510kreport.com/device/K971022 · printed Nov 6, 2026

Cite this page

510(k) Report. “K971022: Chase Sucker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971022

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