510(k) Report

510(k) · Cleared

Cleared

Orthopedic Seats

K862883510(k) TraditionalCleared Aug 14, 198623-day reviewClass I21 CFR 890.3100

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

Mednet, Inc. · INN Chair, Adjustable, Mechanical

Cleared on Aug 14, 1986 after a 23-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Aug 14, 1986
Review
23 days
Class
Class I
Product code
INN
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K862883Source: 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 INN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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  • 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 INN devices

INN Chair, Adjustable, Mechanical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · INN

FDA has decided no INN device since 2007.

Median 510(k) review, days · INN

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

Recalls per year · INN

1in 2022

2008: 12009: 12011: 12013: 12021: 12022: 1
2007high 1 (2008) · low 0 (2007)2026

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

Adverse event reports per year · INN

35in 2025

2007: 82008: 102009: 122010: 162011: 172012: 482013: 52014: 32015: 162016: 262017: 212018: 222019: 292020: 432021: 302022: 322023: 222024: 252025: 35
2007high 48 (2012) · low 3 (2014)2025

MAUDE reports naming product code INN, 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—08
20080—110
20090—112
20100—016
20110—117
20120—048
20130—15
20140—03
20150—016
20160—026
20170—021
20180—022
20190—029
20200—043
20210—130
20220—132
20230—022
20240—025
20250—035
20260—0—

More from Mednet, Inc.

12 FDA decisions under this applicant name. See the company

  • K955782Med-Net StopcocksMednet, Inc. · 1996
  • K862887Upholstered Bucket SeatMednet, Inc. · 1986
  • K862892Caster CarMednet, Inc. · 1986
  • K862885Car SeatMednet, Inc. · 1986
  • K862888Perambulator (Stroller)Mednet, Inc. · 1986

Recent decisions in INN

The INN category page

  • K945650SpiffyThames Valley Children'S Centre · 1994
  • K942397Theradapt Highchair/Stroller InsertTheradapt Products, Inc. · 1994
  • K930520Theradapt (R) Adjustable Classroom ChairTheradapt Products, Inc. · 1993
  • K923753Able Generation Therapy Tilt BenchThe Able Generation, Inc. · 1993
  • K923750Able Generation Booster ChairThe Able Generation, Inc. · 1993

https://510kreport.com/device/K862883 · printed Nov 4, 2026

Cite this page

510(k) Report. “K862883: Orthopedic Seats.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K862883

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