510(k) Report

510(k) · Cleared

Cleared

Neutral Pos-Chair Surgeon Chair

K842030510(k) TraditionalCleared Jul 23, 198466-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

Neutral Pos-Chair Co. · FZK Chair, Surgical, Non-Electrical

Cleared on Jul 23, 1984 after a 66-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jul 23, 1984
Review
66 days
Class
Class I
Product code
FZK
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K842030Source: 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 FZK? 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 FZK devices

FZK Chair, Surgical, Non-Electrical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FZK

FDA has decided no FZK device since 2007.

Median 510(k) review, days · FZK

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

Recalls per year · FZK

No recall names FZK since 2007.

Adverse event reports per year · FZK

1in 2022

2008: 12010: 12011: 22013: 22020: 12022: 1
2007high 2 (2011) · low 0 (2007)2025

MAUDE reports naming product code FZK, 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—01
20090—00
20100—01
20110—02
20120—00
20130—02
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—01
20210—00
20220—01
20230—00
20240—00
20250—00
20260—0—

More from Neutral Pos-Chair Co.

3 FDA decisions under this applicant name. See the company

  • K841952Multi-Purpose Task Support TableNeutral Pos-Chair Co. · 1984
  • K841194Medical Chair, Multipurpose Tast SupportNeutral Pos-Chair Co. · 1984

Recent decisions in FZK

The FZK category page

  • K962528Olympus Mobile Chair/CouchKeymed (Medical & Industrial Equipment), Ltd. · 1996

https://510kreport.com/device/K842030 · printed Nov 6, 2026

Cite this page

510(k) Report. “K842030: Neutral Pos-Chair Surgeon Chair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K842030

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