510(k) · Cleared

Cleared

Pelimit

K792241510(k) TraditionalCleared Nov 30, 197923-day reviewClass II21 CFR 890.5575

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

Colmed, Ltd. · IRN Device, Warning, Overload, External Limb, Powered

Cleared on Nov 30, 1979 after a 23-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided: Nov 30, 1979
Review: 23 days
Class: Class II
Product code: IRN
Recalls: None
Predicates: 0

3 later devices descend from it, 1 citing it directly.

This deviceK792241 PelimitColmed, Ltd. · 1979
Descendant · cites it directly · 2 of its ownK955034 ForceguardImpact Monitors, Inc. · 1996
Descendant · 2 generations on · 1 of its ownK023161 Smartstep SystemAndante Medical Device, Ltd. · 2002
Descendant · 3 generations on · 0 of its ownK060150 Smartstep System/Smarstep Clinic SystemAndante Medical Devices, Ltd. · 2006

Most influential descendants

Showing 3 of 3 · See all

K955034ForceguardImpact Monitors, Inc. · 1996 · cites it directly2descendants
K023161Smartstep SystemAndante Medical Device, Ltd. · 2002 · 2 generations on1descendant
K060150Smartstep System/Smarstep Clinic SystemAndante Medical Devices, Ltd. · 2006 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K792241	Pelimit	Colmed, Ltd.	1979	—
+1	K955034	Forceguard	Impact Monitors, Inc.	1996	—
+2	K023161	Smartstep System	Andante Medical Device, Ltd.	2002	—
+3	K060150	Smartstep System/Smarstep Clinic System	Andante Medical Devices, Ltd.	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
2002	1	0
2006	1	0

FIG. 1 — Lineage of K792241, 1979–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 IRN? 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? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K955034	Forceguard	Impact Monitors, Inc.	1996	2

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.

What does this lineage say?

Of its descendants, K955034 (Impact Monitors, Inc., 1996) has gone furthest, with 2 descendants of its own.

How does its category compare?

All IRN devices

IRN Device, Warning, Overload, External Limb, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IRN

FDA has decided no IRN device since 2007.

Median 510(k) review, days · IRN

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

Recalls per year · IRN

No recall names IRN since 2007.

Adverse event reports per year · IRN

No MAUDE report names IRN since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/K792241 · printed Nov 6, 2026

Cite this page

510(k) Report. “K792241: Pelimit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K792241

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026