510(k) Report

510(k) · Cleared

Cleared

Soni-Lok Scope Stabilizer

K850122510(k) TraditionalCleared Feb 21, 198538-day reviewClass I21 CFR 878.4160

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

Med Surg Designs, Inc. · FXR Holder, Camera, Surgical

Cleared on Feb 21, 1985 after a 38-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Feb 21, 1985
Review
38 days
Class
Class I
Product code
FXR
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K850122Source: 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 FXR devices

FXR Holder, Camera, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FXR

FDA has decided no FXR device since 2007.

Median 510(k) review, days · FXR

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

Recalls per year · FXR

No recall names FXR since 2007.

Adverse event reports per year · FXR

4in 2025

2010: 12019: 42020: 142021: 52022: 372023: 432024: 172025: 4
2007high 43 (2023) · low 0 (2007)2025

MAUDE reports naming product code FXR, 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—01
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—04
20200—014
20210—05
20220—037
20230—043
20240—017
20250—04
20260—0—

More from Med Surg Designs, Inc.

2 FDA decisions under this applicant name. See the company

  • K863639Articular Motion Device (AMD4000)Med Surg Designs, Inc. · 1986

Recent decisions in FXR

The FXR category page

  • K810303Television Camera Holder for SurgeryThe Anspach Effort, Inc. · 1981

https://510kreport.com/device/K850122 · printed Nov 6, 2026

Cite this page

510(k) Report. “K850122: Soni-Lok Scope Stabilizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K850122

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