510(k) Report

510(k) · Cleared

Cleared

Malis Surgical Stool

K890309510(k) TraditionalCleared Feb 14, 198922-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

Valley Forge Scientific Corp. · FZM Stool, Operating-Room

Cleared on Feb 14, 1989 after a 22-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Feb 14, 1989
Review
22 days
Class
Class I
Product code
FZM
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K890309Source: FDA 510(k) database · How lineage is built

Get the monthly Device Review Tracker

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 FZM? 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
Get a 510(k) Report

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 FZM devices

FZM Stool, Operating-Room: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FZM

FDA has decided no FZM device since 2007.

Median 510(k) review, days · FZM

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

Recalls per year · FZM

No recall names FZM since 2007.

Adverse event reports per year · FZM

11in 2025

2009: 12010: 422011: 542012: 142013: 462014: 582015: 592017: 142018: 172019: 42020: 132021: 132022: 102023: 122024: 92025: 11
2007high 59 (2015) · low 0 (2007)2025

MAUDE reports naming product code FZM, 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—01
20100—042
20110—054
20120—014
20130—046
20140—058
20150—059
20160—00
20170—014
20180—017
20190—04
20200—013
20210—013
20220—010
20230—012
20240—09
20250—011
20260—0—

More from Valley Forge Scientific Corp.

27 FDA decisions under this applicant name. See the company

  • K050364Malis 2000 Bipolar Electrosurgical SystemValley Forge Scientific Corp. · 2005
  • K042604Vally Forge Scientific Malis Bipolar Disposable Finger Operated Electrosurgical InstrumentsValley Forge Scientific Corp. · 2004
  • K032601Stryker Interventional Pain RF GeneratorValley Forge Scientific Corp. · 20041 recall
  • K033499Malis Irrigation Module 1000Valley Forge Scientific Corp. · 2003
  • K982229BI-DentValley Forge Scientific Corp. · 1998

https://510kreport.com/device/K890309 · printed Nov 6, 2026

Cite this page

510(k) Report. “K890309: Malis Surgical Stool.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K890309

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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