510(k) Report

510(k) · Cleared

Cleared

Medsurg Circumcision Tray

K920838510(k) TraditionalCleared Oct 15, 1993599-day reviewClass II21 CFR 884.3900

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

Medsurg Industries, Inc. · HFK Mold, Vaginal

Cleared on Oct 15, 1993 after a 599-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Oct 15, 1993
Review
599 days
Class
Class II
Product code
HFK
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 K920838Source: 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 HFK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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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 HFK devices

HFK Mold, Vaginal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HFK

FDA has decided no HFK device since 2007.

Median 510(k) review, days · HFK

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

Recalls per year · HFK

No recall names HFK since 2007.

Adverse event reports per year · HFK

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2025

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

More from Medsurg Industries, Inc.

41 FDA decisions under this applicant name. See the company

  • K920780Medsurg Insertion TrayMedsurg Industries, Inc. · 1994
  • K940175Medsurg Sterile O.R. TowelsMedsurg Industries, Inc. · 1994
  • K934731Medsurg Sterile Imaging ProductsMedsurg Industries, Inc. · 1994
  • K925558InfiltubeMedsurg Industries, Inc. · 1994
  • K934971Sterile Laparotomy SpongesMedsurg Industries, Inc. · 1994

https://510kreport.com/device/K920838 · printed Nov 6, 2026

Cite this page

510(k) Report. “K920838: Medsurg Circumcision Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K920838

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