510(k) Report

510(k) · Cleared

Cleared

Hoyer One-Touch Power Lifter

K860837510(k) TraditionalCleared Mar 27, 198622-day reviewClass I21 CFR 880.5510

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

Ted Hoyer & Co., Inc. · FSA Lift, Patient, Non-Ac-Powered

Cleared on Mar 27, 1986 after a 22-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Mar 27, 1986
Review
22 days
Class
Class I
Product code
FSA
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K860837Source: 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 FSA? 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 FSA devices

FSA Lift, Patient, Non-Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FSA

FDA has decided no FSA device since 2007.

Median 510(k) review, days · FSA

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

Recalls per year · FSA

2in 2022

2007: 72008: 192009: 52010: 12011: 102012: 42013: 32015: 22016: 32017: 12018: 32019: 32020: 2, 1 Class I2021: 42022: 22026 (partial year): 2
2007high 19 (2008) · low 0 (2014)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · FSA

436in 2025

2007: 1992008: 2352009: 2312010: 3442011: 4502012: 9812013: 1,9232014: 1,6022015: 1,4212016: 7352017: 3782018: 3672019: 3932020: 2812021: 2572022: 2642023: 3422024: 3712025: 436
2007high 1,923 (2013) · low 199 (2007)2025

MAUDE reports naming product code FSA, 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—7199
20080—19235
20090—5231
20100—1344
20110—10450
20120—4981
20130—31,923
20140—01,602
20150—21,421
20160—3735
20170—1378
20180—3367
20190—3393
20200—2 (1)281
20210—4257
20220—2264
20230—0342
20240—0371
20250—0436
20260—2—

More from Ted Hoyer & Co., Inc.

2 FDA decisions under this applicant name. See the company

  • K862477Hoyer Digital Electronic ScaleTed Hoyer & Co., Inc. · 1986

Recent decisions in FSA

The FSA category page

  • K942807Surgical Lift SheetSurgin Surgical Instrumentation, Inc. · 1994
  • K930625Sanitas Patient LiftDutton-Lainson Co. · 1993
  • K902141Anolift - Portable & Anolift - GantryAnodyne Corp. · 1990
  • K851844MoliftMadshus A/S · 1985
  • K844976Medi-Man Water Powered Bath Lift & Hydraulic LiftMedi-Man Rehabilitation Products, Inc. · 1985

https://510kreport.com/device/K860837 · printed Nov 5, 2026

Cite this page

510(k) Report. “K860837: Hoyer One-Touch Power Lifter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K860837

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