510(k) Report

510(k) · Cleared

Cleared

GO-Clean

K922110510(k) TraditionalCleared Mar 9, 1994673-day reviewClass II21 CFR 880.5450

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

Viva-Tek Assoc., Inc. · FRR Chamber, Reverse Isolation, Patient Care

Cleared on Mar 9, 1994 after a 673-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Mar 9, 1994
Review
673 days
Class
Class II
Product code
FRR
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 K922110Source: 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.

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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 FRR devices

FRR Chamber, Reverse Isolation, Patient Care: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FRR

FDA has decided no FRR device since 2007.

Median 510(k) review, days · FRR

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

Recalls per year · FRR

No recall names FRR since 2007.

Adverse event reports per year · FRR

No MAUDE report names FRR since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Viva-Tek Assoc., Inc.

2 FDA decisions under this applicant name. See the company

  • K920043AIRESViva-Tek Assoc., Inc. · 1993

https://510kreport.com/device/K922110 · printed Nov 6, 2026

Cite this page

510(k) Report. “K922110: GO-Clean.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K922110

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