510(k) Report

510(k) · Cleared

Cleared

Rota System XL

K931839510(k) TraditionalCleared Nov 22, 1993223-day reviewClass I21 CFR 886.1860

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

Rota Systems Medfurniture, Inc. · HMF Stand, Instrument, Ac-Powered, Ophthalmic

Cleared on Nov 22, 1993 after a 223-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Nov 22, 1993
Review
223 days
Class
Class I
Product code
HMF
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 K931839Source: 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 HMF devices

HMF Stand, Instrument, Ac-Powered, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HMF

FDA has decided no HMF device since 2007.

Median 510(k) review, days · HMF

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

Recalls per year · HMF

No recall names HMF since 2007.

Adverse event reports per year · HMF

2in 2025

2008: 22014: 12015: 12017: 12018: 12020: 32021: 12022: 22023: 12025: 2
2007high 3 (2020) · low 0 (2007)2025

MAUDE reports naming product code HMF, 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—02
20090—00
20100—00
20110—00
20120—00
20130—00
20140—01
20150—01
20160—00
20170—01
20180—01
20190—00
20200—03
20210—01
20220—02
20230—01
20240—00
20250—02
20260—0—

More from Rota Systems Medfurniture, Inc.

2 FDA decisions under this applicant name. See the company

  • K935952Rota System 5000Rota Systems Medfurniture, Inc. · 1994

Recent decisions in HMF

The HMF category page

  • K935952Rota System 5000Rota Systems Medfurniture, Inc. · 1994
  • K935945Rota Datamate IRota Systems,Inc. · 1994
  • K930440Marco International StandMarco Ophthalmic, Inc. · 1993
  • K924780Burton Ophthalmic Exam Unit - Model 2201R.H. Burton Co. · 1993
  • K924771Burton Ophthalmic Stand - Model XL3200R.H. Burton Co. · 1993

https://510kreport.com/device/K931839 · printed Nov 4, 2026

Cite this page

510(k) Report. “K931839: Rota System XL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K931839

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