510(k) · Cleared
ClearedSmartstep System/Smarstep Clinic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Andante Medical Devices, Ltd. · IRN Device, Warning, Overload, External Limb, Powered
Cleared on Feb 23, 2006 as substantially equivalent to K023161 (Andante Medical Device, Ltd., 2002) after a 34-day review. Its family tree reaches back 3 generations to 1977.
- Decided
- Feb 23, 2006
- Review
- 34 days
- Class
- Class II
- Product code
- IRN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K770405 (1977). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK770405 Overload Warning DeviceSynthes (Usa) · 1977
- 2 generations backK955034 ForceguardImpact Monitors, Inc. · 1996
- 1 generation backK023161 Smartstep SystemAndante Medical Device, Ltd. · 2002
- This deviceK060150 Smartstep System/Smarstep Clinic SystemAndante Medical Devices, Ltd. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K770405 | Overload Warning Device | Synthes (Usa) | 1977 | — |
| −2 | K955034 | Forceguard | Impact Monitors, Inc. | 1996 | — |
| −1 | K023161 | Smartstep System | Andante Medical Device, Ltd. | 2002 | — |
| 0 (this device) | 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 |
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? (1)
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 |
|---|---|---|---|
| * | K023161 | Smartstep SystemSummary page 1…Class II; Product Code IRN; Regulation No. 890.5575 7.1.7 Predicate Devices Andante SmartStep TM System (K023161) 7-4 7.1.8 Device Description: The SmartStep TM System is a monitoring &… | 2002 |
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.
What does this lineage say?
- The line of descent spans 29 years and passes through 4 companies; a new generation was cleared every 6.7 years on median.
- None of the 7 ancestors has a recall.
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 T System/ SmartStepT m Clinic System is intended to sense the amount of weight applied to the planter surface of the foot during rehabilitation. The System alerts the user and/or therapist with alarm when the weight exceeded the pre-selected value. Furthermore, the SmartStepTM System/ SmartStep TM Clinic System is intended to be used in any situation in which therapist and/or 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/K060150 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060150: Smartstep System/Smarstep Clinic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060150
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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