510(k) Report

510(k) · Cleared

Cleared

Medcare Suture Scissors (Suture/Gauze Weight)

K861806510(k) TraditionalCleared May 23, 198614-day reviewClass II21 CFR 878.3500

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

Medcomp Technologies, Inc. · KDA Prosthesis, Ptfe/Carbon-Fiber

Cleared on May 23, 1986 after a 14-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
May 23, 1986
Review
14 days
Class
Class II
Product code
KDA
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K861806Source: 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 KDA devices

KDA Prosthesis, Ptfe/Carbon-Fiber: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KDA

FDA has decided no KDA device since 2007.

Median 510(k) review, days · KDA

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

Recalls per year · KDA

No recall names KDA since 2007.

Adverse event reports per year · KDA

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2025

MAUDE reports naming product code KDA, 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—00
20140—00
20150—00
20160—01
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Medcomp Technologies, Inc.

5 FDA decisions under this applicant name. See the company

  • K861804Medcare Suture Removal KitMedcomp Technologies, Inc. · 1986
  • K861805Medcare Forceps (Thumb, Tissue)Medcomp Technologies, Inc. · 1986
  • K861807Medcare Hemostats (Straight, Curved, Mosquito-Tip)Medcomp Technologies, Inc. · 1986
  • K860683Medcare Emergency Shears/Punch & Fin TipsMedcomp Technologies, Inc. · 1986

https://510kreport.com/device/K861806 · printed Nov 6, 2026

Cite this page

510(k) Report. “K861806: Medcare Suture Scissors (Suture/Gauze Weight).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K861806

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