510(k) Report

510(k) · Cleared

Cleared

Overtube for Endscopic Ligator

K924764510(k) TraditionalCleared Mar 15, 1993173-day reviewClass I21 CFR 876.1500

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

Superior Healthcare Group, Inc. · MNK Endoscopic Bite Block

Cleared on Mar 15, 1993 after a 173-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Mar 15, 1993
Review
173 days
Class
Class I
Product code
MNK
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 K924764Source: 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 MNK? 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 MNK devices

MNK Endoscopic Bite Block: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MNK

FDA has decided no MNK device since 2007.

Median 510(k) review, days · MNK

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

Recalls per year · MNK

No recall names MNK since 2007.

Adverse event reports per year · MNK

39in 2025

2012: 12014: 32015: 22016: 52017: 52018: 92019: 162020: 132021: 152022: 112023: 42024: 212025: 39
2007high 39 (2025) · low 0 (2007)2025

MAUDE reports naming product code MNK, 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—01
20130—00
20140—03
20150—02
20160—05
20170—05
20180—09
20190—016
20200—013
20210—015
20220—011
20230—04
20240—021
20250—039
20260—0—

More from Superior Healthcare Group, Inc.

14 FDA decisions under this applicant name. See the company

  • K925530Instrument WarmerSuperior Healthcare Group, Inc. · 1993
  • K905755Non-Sterile Patient Examination GlovesSuperior Healthcare Group, Inc. · 1991
  • K903347Sodium Chloride SolutionSuperior Healthcare Group, Inc. · 1990
  • K904216Sterile Water Solution Catalog # 10000Superior Healthcare Group, Inc. · 1990
  • K903340Sterile Urethral Catheter Procedure KitsSuperior Healthcare Group, Inc. · 19901 Class I recall

Recent decisions in MNK

The MNK category page

  • K944049Oxygen MouthguardEndovations, Inc. · 1994
  • K933537Encompas Comfort Block # 0B-10Encompas Unlimited, Inc. · 1994
  • K931044Oxy-BlocGi Supply · 1993
  • K914978OxyguardStantex Pty, Ltd. · 1992
  • K896691Bite BlockEndoscopix · 1990

https://510kreport.com/device/K924764 · printed Nov 6, 2026

Cite this page

510(k) Report. “K924764: Overtube for Endscopic Ligator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K924764

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