510(k) Report

510(k) · Cleared

Cleared

Kambin Laminectomy Frame

K874494510(k) TraditionalCleared Nov 23, 198721-day reviewClass I21 CFR 878.4950

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

Avec Scientific Design Corp. · LWG Surgical Table Cushion

Cleared on Nov 23, 1987 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Nov 23, 1987
Review
21 days
Class
Class I
Product code
LWG
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K874494Source: 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 LWG? 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 LWG devices

LWG Surgical Table Cushion: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LWG

FDA has decided no LWG device since 2007.

Median 510(k) review, days · LWG

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

Recalls per year · LWG

No recall names LWG since 2007.

Adverse event reports per year · LWG

20in 2025

2007: 32012: 12014: 12015: 12019: 12022: 12024: 12025: 20
2007high 20 (2025) · low 0 (2008)2025

MAUDE reports naming product code LWG, 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—03
20080—00
20090—00
20100—00
20110—00
20120—01
20130—00
20140—01
20150—01
20160—00
20170—00
20180—00
20190—01
20200—00
20210—00
20220—01
20230—00
20240—01
20250—020
20260—0—

More from Avec Scientific Design Corp.

6 FDA decisions under this applicant name. See the company

  • K883295Chop Spine FrameAvec Scientific Design Corp. · 1988
  • K872544Irrigation Pressure MonitorAvec Scientific Design Corp. · 1987
  • K871981Bilateral Continuous Passive Motion DeviceAvec Scientific Design Corp. · 1987
  • K871900Over Drape Leg HolderAvec Scientific Design Corp. · 1987
  • K871982Tourniquet Pressure RegulatorAvec Scientific Design Corp. · 1987

Recent decisions in LWG

The LWG category page

  • K883295Chop Spine FrameAvec Scientific Design Corp. · 1988
  • K882520Shoulder Bolster, Knee, Ankle & Leg Support PadsKarlin Technology, Inc. · 1988
  • K873690Cedar (TM) Pelvic CushionCedar Surgical, Inc. · 1987

https://510kreport.com/device/K874494 · printed Nov 6, 2026

Cite this page

510(k) Report. “K874494: Kambin Laminectomy Frame.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K874494

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