510(k) Report

510(k) · Cleared

Cleared

Life-Span Cable

K873361510(k) TraditionalCleared Nov 9, 198780-day reviewClass II21 CFR 890.1175

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

Chemfet Corp. · IKD Cable, Electrode

Cleared on Nov 9, 1987 after an 80-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Nov 9, 1987
Review
80 days
Class
Class II
Product code
IKD
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K873361Source: 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.

Planning a device in IKD? 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?

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 IKD devices

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

FDA decisions per year · IKD

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IKD

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

Recalls per year · IKD

1in 2019

2008: 12011: 22019: 1
2007high 2 (2011) · low 0 (2007)2026

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

Adverse event reports per year · IKD

42in 2025

2007: 32008: 42009: 52010: 22011: 22012: 32013: 42014: 32015: 32016: 572017: 332018: 52019: 42020: 72021: 122022: 172023: 72024: 102025: 42
2007high 57 (2016) · low 2 (2010)2025

MAUDE reports naming product code IKD, 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
20071—03
20080—14
20090—05
20100—02
20110—22
20120—03
20130—04
20140—03
20150—03
20160—057
20170—033
20180—05
20190—14
20200—07
20210—012
20220—017
20230—07
20240—010
20250—042
20260—0—

More from Chemfet Corp.

3 FDA decisions under this applicant name. See the company

  • K871922Portable PH, MV, Temp Meter W/Auto. Temp Compensa.Chemfet Corp. · 1987
  • K871921General Purpose Combination PH ElectrodeChemfet Corp. · 1987

Recent decisions in IKD

The IKD category page

  • K070926Electrode/Extension Cables, Models AtarOscor, Inc. · 20072 Class I recalls
  • K992372The LeadawayTherapy Equipment, Inc. · 1999
  • K935260Physiometrix Cable Adapter ModificationPhysiometrix, Inc. · 1993
  • K834583Clear Leads-Radiotransparent WiresQuinton, Inc. · 1984
  • K800934R2 Esu Cable-Adapter Models 160,161R2 Corp. · 1980

https://510kreport.com/device/K873361 · printed Nov 4, 2026

Cite this page

510(k) Report. “K873361: Life-Span Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K873361

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