510(k) Report

510(k) · Cleared

Cleared

Adjustable Fork Retractor

K833604510(k) TraditionalCleared Jan 3, 198483-day reviewClass I21 CFR 874.4420

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

Microtek Medical, Inc. · KAL Retractor, Ent

Cleared on Jan 3, 1984 after an 83-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jan 3, 1984
Review
83 days
Class
Class I
Product code
KAL
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K833604Source: 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 KAL? 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 KAL devices

KAL Retractor, Ent: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KAL

FDA has decided no KAL device since 2007.

Median 510(k) review, days · KAL

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

Recalls per year · KAL

No recall names KAL since 2007.

Adverse event reports per year · KAL

3in 2023

2013: 22014: 12016: 12017: 22019: 12020: 12022: 12023: 3
2007high 3 (2023) · low 0 (2007)2025

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

More from Microtek Medical, Inc.

24 FDA decisions under this applicant name. See the company

  • K110358Venodyne V810Microtek Medical, Inc. · 2011
  • K102971Freedomaire Iii Surgical Helmet System Model 10322STKMicrotek Medical, Inc. · 2011
  • K062899Microtek Medical Surgical Gown/TogaMicrotek Medical, Inc. · 2007
  • K060200Microtek Medical Warming DrapeMicrotek Medical, Inc. · 20061 recall
  • K050322Microtek Equipment DrapesMicrotek Medical, Inc. · 200517 recalls

Recent decisions in KAL

The KAL category page

  • K870758Small Mastoid RetractorTreace Medical, Inc. · 1987
  • K772392Allport Mastoid RetractorsEdward Weck, Inc. · 1978
  • K772381Ring Handle & RetractorsEdward Weck, Inc. · 1978
  • K760851Converse Altar RetractorV. Mueller O.V. Baxter Healthcare Corp. · 1977

https://510kreport.com/device/K833604 · printed Nov 3, 2026

Cite this page

510(k) Report. “K833604: Adjustable Fork Retractor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K833604

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