510(k) · Cleared
ClearedSmartstep System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Andante Medical Device, Ltd. · IRN Device, Warning, Overload, External Limb, Powered
Cleared on Dec 10, 2002 as substantially equivalent to K950656 (Orbitec Technologies Corp., 1995) and 2 other predicates after a 78-day review. Its family tree reaches back 2 generations to 1977. 1 later device descends from it.
- Decided
- Dec 10, 2002
- Review
- 78 days
- Class
- Class II
- Product code
- IRN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K770405 (1977). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK770405 Overload Warning DeviceSynthes (Usa) · 1977
- 1 generation backK955034 ForceguardImpact Monitors, Inc. · 1996
- This deviceK023161 Smartstep SystemAndante Medical Device, Ltd. · 2002
- Descendant · cites it directly · 0 of its ownK060150 Smartstep System/Smarstep Clinic SystemAndante Medical Devices, Ltd. · 2006
Most influential descendants
Showing 1 of 1 · See all- K060150Smartstep System/Smarstep Clinic SystemAndante Medical Devices, Ltd. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K770405 | Overload Warning Device | Synthes (Usa) | 1977 | — |
| −1 | K955034 | Forceguard | Impact Monitors, Inc. | 1996 | — |
| 0 (this device) | K023161 | Smartstep System | Andante Medical Device, Ltd. | 2002 | — |
| +1 | K060150 | Smartstep System/Smarstep Clinic System | Andante Medical Devices, Ltd. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1988 | 1 | 0 |
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K950656 | Ped AlertSummary page 2…7-3 Predicate Device: Ped Alert Plenet manufactured by Planet Products Corp USA (former Orbitec Technologies Corp.) cleared under K950656. ForceGuard manufactured by Impact Monitors, Inc. USA cleared under K95.5034. AccuTreadTM System man… | 1995 |
| * | K955034 | Forceguard | 1996 |
| * | K991313 | Accutred ShoeSummary page 2…ard manufactured by Impact Monitors, Inc. USA cleared under K95.5034. AccuTreadTM System manufactured by Chattanooga Group Inc. cleared under K991313. Performance Standards: No performance standards have been established for such device under Section 514 of the Fede… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060150 | Smartstep System/Smarstep Clinic System | 2006 | 0 |
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?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 19.1 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K060150 (Andante Medical Devices, Ltd., 2006) has gone furthest, with 0 descendants of its own.
How does its category compare?
All IRN devicesIRN 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 | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Smartstep System is intended to sense the amount of weight applied to the plantar surface of the foot during rehabilitation. The device alerts the user andor therapist with alarm when the weight exceeded the pre-selected value. Furthermore, the Smartstep System is intended to be used in any situation in which therapist andor patient would benefit from objectively assessing the amount of weight that is being applied to a lower limb.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023161 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023161: Smartstep System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023161
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026