510(k) · Cleared

Cleared

Ped Alert

K950656510(k) TraditionalCleared Oct 25, 1995254-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

Orbitec Technologies Corp. · IRN Device, Warning, Overload, External Limb, Powered

Cleared on Oct 25, 1995 after a 254-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided: Oct 25, 1995
Review: 254 days
Class: Class II
Product code: IRN
Recalls: None
Predicates: 0

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

This deviceK950656 Ped AlertOrbitec Technologies Corp. · 1995
Descendant · cites it directly · 1 of its ownK023161 Smartstep SystemAndante Medical Device, Ltd. · 2002
Descendant · 2 generations on · 0 of its ownK060150 Smartstep System/Smarstep Clinic SystemAndante Medical Devices, Ltd. · 2006

Most influential descendants

Showing 2 of 2 · See all

K023161Smartstep SystemAndante Medical Device, Ltd. · 2002 · cites it directly1descendant
K060150Smartstep System/Smarstep Clinic SystemAndante Medical Devices, Ltd. · 2006 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K950656	Ped Alert	Orbitec Technologies Corp.	1995	—
+1	K023161	Smartstep System	Andante Medical Device, Ltd.	2002	—
+2	K060150	Smartstep System/Smarstep Clinic System	Andante Medical Devices, Ltd.	2006	—

Descendants by year cleared

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

FIG. 1 — Lineage of K950656, 1995–2006Source: 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.

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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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K023161	Smartstep System	Andante Medical Device, Ltd.	2002	1

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, K023161 (Andante Medical Device, Ltd., 2002) has gone furthest, with 1 descendant 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/K950656 · printed Nov 6, 2026

Cite this page

510(k) Report. “K950656: Ped Alert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950656

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Record history

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