510(k) Report

510(k) · Cleared

Cleared

Meddev Multarray (TM) Medical Examination Light

K931197510(k) TraditionalCleared Sep 23, 1993198-day reviewClass I21 CFR 880.6320

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

Meddev International Corp. · KZF Device, Medical Examination, Ac Powered

Cleared on Sep 23, 1993 after a 198-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Sep 23, 1993
Review
198 days
Class
Class I
Product code
KZF
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 K931197Source: 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 KZF? 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 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 KZF devices

KZF Device, Medical Examination, Ac Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KZF

FDA has decided no KZF device since 2007.

Median 510(k) review, days · KZF

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

Recalls per year · KZF

No recall names KZF since 2007.

Adverse event reports per year · KZF

9in 2025

2007: 102008: 52009: 22010: 132011: 62012: 82013: 22014: 52015: 32016: 132017: 102018: 62019: 272020: 472021: 212022: 702023: 832024: 202025: 9
2007high 83 (2023) · low 2 (2009)2025

MAUDE reports naming product code KZF, 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—010
20080—05
20090—02
20100—013
20110—06
20120—08
20130—02
20140—05
20150—03
20160—013
20170—010
20180—06
20190—027
20200—047
20210—021
20220—070
20230—083
20240—020
20250—09
20260—0—

More from Meddev International Corp.

4 FDA decisions under this applicant name. See the company

  • K940284Meddev Multarray Medical Examining Light ModificationMeddev International Corp. · 1994
  • K874562SecuratrodeMeddev International Corp. · 1988
  • K771435Urinary Leg Bag, SteoileMeddev International Corp. · 1977

Recent decisions in KZF

The KZF category page

  • K954943NevoscopeNizar A. Mullani · 1996
  • K952835Welch Allyn Video EpiscopeWelch Allyn, Inc. · 1995
  • K945507H 5100, H 5200, H 5300Rudolf Riester GmbH & Co. KG · 1994
  • K941869Splint, Pneumatic, Arm & Splint, Pneumatic, LegThe Lighthouse For the Blind, Inc. · 1994
  • K936088Wave Fluorescent MagnifierBurton Medical Products Corp. · 1994

https://510kreport.com/device/K931197 · printed Nov 5, 2026

Cite this page

510(k) Report. “K931197: Meddev Multarray (TM) Medical Examination Light.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K931197

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