510(k) Report

510(k) · Cleared

Cleared

Auto-Clip

K771021510(k) TraditionalCleared Jun 14, 19778-day reviewClass II21 CFR 870.3250

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

Axiom Medical, Inc. · DSS Clip, Vascular

Cleared on Jun 14, 1977 after an 8-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.

Decided
Jun 14, 1977
Review
8 days
Class
Class II
Product code
DSS
Recalls
None
Predicates
0

5 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared1997: 1 descendant cleared2004: 1 descendant cleared2025: 1 descendant cleared2019: 1 descendant cleared19801990200020102020
  1. This deviceK771021 Auto-ClipAxiom Medical, Inc. · 1977
  2. Descendant · cites it directly · 4 of its ownK972745 Titanium Hemostatic ClipEisner USA, Inc. · 1997
  3. Descendant · cites it directly · 3 of its ownK981645 Titanium Hemostatic ClipVitalitec Int'L., Inc. · 1998
  4. Descendant · 2 generations on · 0 of its ownK242541 Gem ZipclipSynovis Micro Companies Alliance A Subsidiary of Baxter Int · 2025
  5. Descendant · 2 generations on · 0 of its ownK192711 Dannik Titanium Ligation ClipDannik · 2019
  6. Descendant · 2 generations on · 0 of its ownK040602 Sureline Laparoscopic Clip Applier with Implantable Titanium ClipsDesign Standards Corp. · 2004

Most influential descendants

Showing 5 of 5 · See all
  • K972745Titanium Hemostatic ClipEisner USA, Inc. · 1997 · cites it directly4descendants
  • K981645Titanium Hemostatic ClipVitalitec Int'L., Inc. · 1998 · cites it directly3descendants
  • K242541Gem ZipclipSynovis Micro Companies Alliance A Subsidiary of Baxter Int · 2025 · 2 generations on0descendants
  • K192711Dannik Titanium Ligation ClipDannik · 2019 · 2 generations on0descendants
  • K040602Sureline Laparoscopic Clip Applier with Implantable Titanium ClipsDesign Standards Corp. · 2004 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K771021Auto-ClipAxiom Medical, Inc.1977—
+1K972745Titanium Hemostatic ClipEisner USA, Inc.1997—
+1K981645Titanium Hemostatic ClipVitalitec Int'L., Inc.1998—
+2K242541Gem ZipclipSynovis Micro Companies Alliance A Subsidiary of Baxter Int2025—
+2K192711Dannik Titanium Ligation ClipDannik2019—
+2K040602Sureline Laparoscopic Clip Applier with Implantable Titanium ClipsDesign Standards Corp.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199810
200410
201910
202510
FIG. 1 — Lineage of K771021, 1977–2025Source: FDA 510(k) summaries, read by 510(k) Report · 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 DSS? 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? (5)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K972745Titanium Hemostatic ClipEisner USA, Inc.19974
K981645Titanium Hemostatic ClipVitalitec Int'L., Inc.19983

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.

What does this lineage say?

  • Of its descendants, K972745 (Eisner USA, Inc., 1997) has gone furthest, with 4 descendants of its own.

How does its category compare?

All DSS devices

DSS Clip, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DSS

FDA has decided no DSS device since 2007.

Median 510(k) review, days · DSS

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

Recalls per year · DSS

No recall names DSS since 2007.

Adverse event reports per year · DSS

2in 2025

2007: 52008: 22009: 12012: 52014: 12016: 22017: 12019: 82020: 182022: 42023: 42025: 2
2007high 18 (2020) · low 0 (2010)2025

MAUDE reports naming product code DSS, 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—05
20080—02
20090—01
20100—00
20110—00
20120—05
20130—00
20140—01
20150—00
20160—02
20170—01
20180—00
20190—08
20200—018
20210—00
20220—04
20230—04
20240—00
20250—02
20260—0—

More from Axiom Medical, Inc.

28 FDA decisions under this applicant name. See the company

  • K993592Axiom Multipurpose Wound DrainAxiom Medical, Inc. · 2000
  • K971851Interpleural Anesthesia CatheterAxiom Medical, Inc. · 1998
  • K965146Flat Closed Wound Drain with TrocarAxiom Medical, Inc. · 1997
  • K934895Glassman Silicone CatheterAxiom Medical, Inc. · 1994
  • K922760Atraum Wound Dressing--ModificationAxiom Medical, Inc. · 1992

Recent decisions in DSS

The DSS category page

  • K983744Mcas (Modular Clip Applier System)Applied Medical Resources · 1999
  • K961333Heartport Multifire Clip ApplierHeartport, Inc. · 1996
  • K920104Identi Loops Degania SiliconePuritas Health Care, Inc. · 1992
  • K920676Rmi SofclampResearch Medical, Inc. · 1992
  • K914523Cri Vessel Occlusin System/Cri Occlusion CoilCatheter Research C/O Burditt, Bowles & Radzius · 1992

https://510kreport.com/device/K771021 · printed Nov 6, 2026

Cite this page

510(k) Report. “K771021: Auto-Clip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K771021

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