510(k) Report

PMA · Approved

Approved

Parastep-I

P900038PMAApproved Apr 20, 19941,430-day reviewClass III

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

Sigmedics, Inc. · MKD Stimulator, Functional Walking Neuromuscular, Non-Invasive

Approved on Apr 20, 1994 through premarket approval, which rests on the device’s own clinical evidence after a 1,430-day review.

Decided
Apr 20, 1994
Review
1,430 days
Class
Class III
Product code
MKD
Recalls
None

PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.

FIG. 1 — Lineage of P900038Source: FDA PMA database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MKD? 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
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Does it have a predicate?

PMA decisions do not claim a predicate device.

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 MKD devices

MKD Stimulator, Functional Walking Neuromuscular, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MKD

FDA has decided no MKD device since 2007.

Median 510(k) review, days · MKD

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

Recalls per year · MKD

No recall names MKD since 2007.

Adverse event reports per year · MKD

5in 2014

2014: 5
2007high 5 (2014) · low 0 (2007)2025

MAUDE reports naming product code MKD, 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
20130—00
20140—05
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

https://510kreport.com/device/P900038 · printed Nov 6, 2026

Cite this page

510(k) Report. “P900038: Parastep-I.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P900038

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