510(k) Report

510(k) · Cleared

Cleared

Hemostat

K770158510(k) TraditionalCleared Jan 31, 19777-day reviewClass I21 CFR 872.4565

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

Deringer-Ney, Inc. · EMD Hemostat, Surgical

Cleared on Jan 31, 1977 after a 7-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jan 31, 1977
Review
7 days
Class
Class I
Product code
EMD
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K770158Source: 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 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 EMD devices

EMD Hemostat, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EMD

FDA has decided no EMD device since 2007.

Median 510(k) review, days · EMD

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

Recalls per year · EMD

No recall names EMD since 2007.

Adverse event reports per year · EMD

1in 2019

2009: 12010: 12014: 22015: 12019: 1
2007high 2 (2014) · low 0 (2007)2025

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

More from Deringer-Ney, Inc.

46 FDA decisions under this applicant name. See the company

  • K933178GDC 3509Deringer-Ney, Inc. · 1993
  • K930481Dental Casting Alloy Modification-PF-4Deringer-Ney, Inc. · 1993
  • K930482Dental Casting Alloy, Modification - PF-3Deringer-Ney, Inc. · 1993
  • K925273GDC 3445Deringer-Ney, Inc. · 1992
  • K920922GDC 3367Deringer-Ney, Inc. · 1992

Recent decisions in EMD

The EMD category page

  • K920883Hemostat, Surgical (Various Types)S.T.S Instruments · 1992

https://510kreport.com/device/K770158 · printed Nov 6, 2026

Cite this page

510(k) Report. “K770158: Hemostat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K770158

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