510(k) Report

510(k) · Cleared

Cleared

Perambulator (Stroller)

K862888510(k) TraditionalCleared Aug 13, 198622-day reviewClass I21 CFR 890.3850

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

Mednet, Inc. · LBE Stroller, Adaptive

Cleared on Aug 13, 1986 after a 22-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Aug 13, 1986
Review
22 days
Class
Class I
Product code
LBE
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K862888Source: 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 LBE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LBE device

  1. #1 K223533 Little Wave Arc; Little Wave Flipscore 5.9 · 1 generation · no Class I recall
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 LBE devices

LBE Stroller, Adaptive: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LBE

1in 2023

2013: 12023: 1
2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LBE

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

Recalls per year · LBE

No recall names LBE since 2007.

Adverse event reports per year · LBE

1in 2025

2017: 32022: 12024: 12025: 1
2007high 3 (2017) · low 0 (2007)2025

MAUDE reports naming product code LBE, 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—00
20110—00
20120—00
20131—00
20140—00
20150—00
20160—00
20170—03
20180—00
20190—00
20200—00
20210—00
20220—01
20231—00
20240—01
20250—01
20260—0—

More from Mednet, Inc.

12 FDA decisions under this applicant name. See the company

  • K955782Med-Net StopcocksMednet, Inc. · 1996
  • K862883Orthopedic SeatsMednet, Inc. · 1986
  • K862887Upholstered Bucket SeatMednet, Inc. · 1986
  • K862892Caster CarMednet, Inc. · 1986
  • K862885Car SeatMednet, Inc. · 1986

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The LBE category page

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  • K130644Pediatric Folding WheelchairColumbia Medical Mfg, LLC · 2013
  • K863450Sulky SpecialAsc Corp. · 1986
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  • K820591Mechanical ChairKaye Products, Inc. · 1982

https://510kreport.com/device/K862888 · printed Nov 4, 2026

Cite this page

510(k) Report. “K862888: Perambulator (Stroller).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K862888

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