510(k) Report

FDA product code · General hospital

Chamber, Reverse Isolation, Patient Care

FRRClass II21 CFR 880.5450510(k) required1 decision since 19940 recalls

1 FDA decision since 1994. No recall names this code.

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

FIG. A — Illustration, general hospital panel

Twenty years of FRR at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

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—
FIG. 1 — FRR by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in FRR? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

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What has FDA decided in FRR lately?

  • K922110GO-CleanViva-Tek Assoc., Inc. · 1994

The one FRR decision →

Related product codes

Other codes under 21 CFR 880.5450.

LGM Chamber, Patient IsolationLGN Chamber, Patient Transport Isolation