510(k) Report

510(k) · Cleared

Cleared

Monopolar Cautery Conical Tip #TM-1702

K873654510(k) TraditionalCleared Dec 15, 198796-day reviewClass II21 CFR 878.4400

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

Arthropedics, Inc. · JOS Electrode, Electrosurgical

Cleared on Dec 15, 1987 after a 96-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Dec 15, 1987
Review
96 days
Class
Class II
Product code
JOS
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K873654Source: 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 JOS devices

JOS Electrode, Electrosurgical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JOS

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JOS

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

Recalls per year · JOS

2in 2019

2008: 12012: 22016: 12019: 2
2007high 2 (2012) · low 0 (2007)2026

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

Adverse event reports per year · JOS

6in 2025

2007: 292008: 372009: 622010: 142011: 52012: 72013: 52014: 72015: 132016: 62017: 72018: 102019: 172020: 122021: 52022: 82023: 92024: 32025: 6
2007high 62 (2009) · low 3 (2024)2025

MAUDE reports naming product code JOS, 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—029
20080—137
20090—062
20100—014
20110—05
20120—27
20130—05
20140—07
20150—013
20161—16
20170—07
20180—010
20190—217
20200—012
20210—05
20220—08
20230—09
20240—03
20250—06
20260—0—
Cite this page

510(k) Report. “K873654: Monopolar Cautery Conical Tip #TM-1702.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K873654

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