510(k) Report

510(k) · Cleared

Cleared

Converse Altar Retractor

K760851510(k) TraditionalCleared Mar 10, 1977146-day reviewClass I21 CFR 874.4420

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

V. Mueller O.V. Baxter Healthcare Corp. · KAL Retractor, Ent

Cleared on Mar 10, 1977 after a 146-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Mar 10, 1977
Review
146 days
Class
Class I
Product code
KAL
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K760851Source: FDA 510(k) database · How lineage is built

Get the monthly Device Review Tracker

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 KAL? 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
Get a 510(k) Report

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 KAL devices

KAL Retractor, Ent: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KAL

FDA has decided no KAL device since 2007.

Median 510(k) review, days · KAL

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

Recalls per year · KAL

No recall names KAL since 2007.

Adverse event reports per year · KAL

3in 2023

2013: 22014: 12016: 12017: 22019: 12020: 12022: 12023: 3
2007high 3 (2023) · low 0 (2007)2025

MAUDE reports naming product code KAL, 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—00
20130—02
20140—01
20150—00
20160—01
20170—02
20180—00
20190—01
20200—01
20210—00
20220—01
20230—03
20240—00
20250—00
20260—0—
Cite this page

510(k) Report. “K760851: Converse Altar Retractor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K760851

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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