510(k) Report

510(k) · Cleared

Cleared

Model SKCK Sterile Knob Cover Kit

K870662510(k) TraditionalCleared Oct 28, 1987251-day reviewClass II21 CFR 868.2775

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

Life-Tech Intl., Inc. · BXM Stimulator, Nerve, Ac-Powered

Cleared on Oct 28, 1987 after a 251-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Oct 28, 1987
Review
251 days
Class
Class II
Product code
BXM
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K870662Source: 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 BXM? 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 BXM devices

BXM Stimulator, Nerve, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BXM

FDA has decided no BXM device since 2007.

Median 510(k) review, days · BXM

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

Recalls per year · BXM

No recall names BXM since 2007.

Adverse event reports per year · BXM

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2025

MAUDE reports naming product code BXM, 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—01
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Life-Tech Intl., Inc.

68 FDA decisions under this applicant name. See the company

  • K001129Prolong, Models PL50, PL100, PL150Life-Tech Intl., Inc. · 20001 recall
  • K954505EZ StimLife-Tech Intl., Inc. · 1996
  • K955031MaxistimLife-Tech Intl., Inc. · 1996
  • K954315PVC Abdominal/Rectal Pressure CatheterLife-Tech Intl., Inc. · 1995
  • K954341Urodynamics Tubing and Infusion SetsLife-Tech Intl., Inc. · 1995

Recent decisions in BXM

The BXM category page

  • K013215Modified Ins-1 Intraoperative Nerve Surveillance SystemNuvasive, Inc. · 2001
  • K002677Nuvasive Ins-1 Intraoperative Nerve Surveillance SystemNuvasive, Inc. · 2000
  • K921498Ver Med A10011 PNS Dual Element ElectrodeVermont Medical, Inc. · 1993

https://510kreport.com/device/K870662 · printed Nov 5, 2026

Cite this page

510(k) Report. “K870662: Model SKCK Sterile Knob Cover Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K870662

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