510(k) Report

510(k) · Cleared

Cleared

Invalift

K910830510(k) TraditionalCleared Jun 9, 1992468-day reviewClass II21 CFR 880.6775

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

American Invalift Corp. · FRZ Device, Patient Transfer, Powered

Cleared on Jun 9, 1992 after a 468-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jun 9, 1992
Review
468 days
Class
Class II
Product code
FRZ
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K910830Source: 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 FRZ? 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)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All FRZ devices

FRZ Device, Patient Transfer, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FRZ

1in 2013

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

2026 to Oct 25, outlined.

Median 510(k) review, days · FRZ

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

Recalls per year · FRZ

No recall names FRZ since 2007.

Adverse event reports per year · FRZ

3in 2025

2010: 22012: 52013: 22014: 32015: 22016: 22017: 32018: 22019: 22021: 32023: 42024: 22025: 3
2007high 5 (2012) · low 0 (2007)2025

MAUDE reports naming product code FRZ, 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—00
20090—00
20100—02
20110—00
20120—05
20131—02
20140—03
20150—02
20160—02
20170—03
20180—02
20190—02
20200—00
20210—03
20220—00
20230—04
20240—02
20250—03
20260—0—

Recent decisions in FRZ

The FRZ category page

  • K121929Zephyr 'X-Series Patient Transfer SledDiacor, Inc. · 2013
  • K841728Lci Medical Inc Air/PalLehigh Consolidated Industries · 1984
  • K834585Celltrak-BR&D Systems, Inc. · 1984
  • K840796Tender Lifting CareLancer Assoc. · 1984

https://510kreport.com/device/K910830 · printed Nov 5, 2026

Cite this page

510(k) Report. “K910830: Invalift.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K910830

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