510(k) Report

510(k) · Cleared

Cleared

Small Vessel Cannula

K760624510(k) TraditionalCleared Sep 17, 19764-day reviewClass I21 CFR 870.4500

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

Cobe Laboratories, Inc. · DWS Instruments, Surgical, Cardiovascular

Cleared on Sep 17, 1976 after a 4-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Sep 17, 1976
Review
4 days
Class
Class I
Product code
DWS
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared19801990200020102020
  1. This deviceK760624 Small Vessel CannulaCobe Laboratories, Inc. · 1976
  2. Descendant · cites it directly · 0 of its ownK971019 Chase Vessel CannulaChase Medical, Inc. · 1997

Most influential descendants

Showing 1 of 1 · See all
  • K971019Chase Vessel CannulaChase Medical, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K760624Small Vessel CannulaCobe Laboratories, Inc.1976—
+1K971019Chase Vessel CannulaChase Medical, Inc.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
FIG. 1 — Lineage of K760624, 1976–1997Source: 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.

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  • 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? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K971019Chase Vessel CannulaChase Medical, Inc.19970

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, K971019 (Chase Medical, Inc., 1997) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DWS devices

DWS Instruments, Surgical, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DWS

FDA has decided no DWS device since 2007.

Median 510(k) review, days · DWS

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

Recalls per year · DWS

1in 2022

2010: 12011: 12016: 12022: 1
2007high 1 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DWS

12in 2025

2007: 202008: 152009: 442010: 272011: 552012: 332013: 342014: 432015: 262016: 332017: 402018: 602019: 282020: 282021: 322022: 352023: 182024: 482025: 12
2007high 60 (2018) · low 12 (2025)2025

MAUDE reports naming product code DWS, 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—020
20080—015
20090—044
20100—127
20110—155
20120—033
20130—034
20140—043
20150—026
20160—133
20170—040
20180—060
20190—028
20200—028
20210—032
20220—135
20230—018
20240—048
20250—012
20260—0—
Cite this page

510(k) Report. “K760624: Small Vessel Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K760624

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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