510(k) Report

510(k) · Cleared

Cleared

Isi Self-Supporting Arm

K925005510(k) TraditionalCleared Apr 29, 1993209-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

Instrumentation Specialties, Inc. · BWN Table And Attachments, Operating-Room

Cleared on Apr 29, 1993 after a 209-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Apr 29, 1993
Review
209 days
Class
Class I
Product code
BWN
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K925005Source: 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 BWN? 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 BWN devices

BWN Table And Attachments, Operating-Room: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BWN

FDA has decided no BWN device since 2007.

Median 510(k) review, days · BWN

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

Recalls per year · BWN

1in 2021

2013: 12021: 12026 (partial year): 1
2007high 1 (2013) · low 0 (2007)2026

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

Adverse event reports per year · BWN

14in 2025

2007: 62008: 42009: 32011: 12012: 72013: 62014: 22015: 22018: 12019: 72020: 92021: 162022: 62023: 502024: 512025: 14
2007high 51 (2024) · low 0 (2010)2025

MAUDE reports naming product code BWN, 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—06
20080—04
20090—03
20100—00
20110—01
20120—07
20130—16
20140—02
20150—02
20160—00
20170—00
20180—01
20190—07
20200—09
20210—116
20220—06
20230—050
20240—051
20250—014
20260—1—

More from Instrumentation Specialties, Inc.

2 FDA decisions under this applicant name. See the company

  • K881101K Orthopedic TableInstrumentation Specialties, Inc. · 1988

Recent decisions in BWN

The BWN category page

  • K942699Airframe Surgical Drape SupportAlpha Surgical, Inc. · 1994
  • K935441Infinitech Breath EZInfinitech, Inc. · 1994
  • K922288Holder, Pediatric PositionYamashita and Hemsley Business Trust · 1993
  • K910783Shampaine Model 3800 or Muranaka Model or-604MSmith & Nephew Equipment Group · 1991
  • K902865Baumer Surgical TableSds Dental, Inc. · 1990

https://510kreport.com/device/K925005 · printed Nov 4, 2026

Cite this page

510(k) Report. “K925005: Isi Self-Supporting Arm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K925005

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