510(k) Report

510(k) · Cleared

Cleared

Force Guard I

K882974510(k) TraditionalCleared Nov 4, 1988112-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

Boulder Impact Monitors, Inc. · IRN Device, Warning, Overload, External Limb, Powered

Cleared on Nov 4, 1988 after a 112-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.

Decided
Nov 4, 1988
Review
112 days
Class
Class II
Product code
IRN
Recalls
None
Predicates
0

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

Descendants, by year cleared 1996: 2 descendants cleared2002: 1 descendant cleared2006: 1 descendant cleared1990200020102020
  1. This deviceK882974 Force Guard IBoulder Impact Monitors, Inc. · 1988
  2. Descendant · cites it directly · 2 of its ownK955034 ForceguardImpact Monitors, Inc. · 1996
  3. Descendant · 2 generations on · 1 of its ownK023161 Smartstep SystemAndante Medical Device, Ltd. · 2002
  4. Descendant · 3 generations on · 0 of its ownK060150 Smartstep System/Smarstep Clinic SystemAndante Medical Devices, Ltd. · 2006
  5. Descendant · cites it directly · 0 of its ownK960307 Index ShoeOrthopedic Technology Research, Inc. · 1996

Most influential descendants

Showing 4 of 4 · 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
  • K960307Index ShoeOrthopedic Technology Research, Inc. · 1996 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K882974Force Guard IBoulder Impact Monitors, Inc.1988—
+1K955034ForceguardImpact Monitors, Inc.1996—
+2K023161Smartstep SystemAndante Medical Device, Ltd.2002—
+3K060150Smartstep System/Smarstep Clinic SystemAndante Medical Devices, Ltd.2006—
+1K960307Index ShoeOrthopedic Technology Research, Inc.1996—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199620
200210
200610
FIG. 1 — Lineage of K882974, 1988–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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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? (4)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K955034ForceguardImpact Monitors, Inc.19962
K960307Index ShoeOrthopedic Technology Research, Inc.19960

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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

Recent decisions in IRN

The IRN category page

  • K060150Smartstep System/Smarstep Clinic SystemAndante Medical Devices, Ltd. · 2006
  • K023161Smartstep SystemAndante Medical Device, Ltd. · 2002
  • K991313Accutred ShoeOrthopedic Technology Research, Inc. · 1999
  • K962591Foot Weight AlarmCleveland Medical Devices, Inc. · 1996
  • K960307Index ShoeOrthopedic Technology Research, Inc. · 1996

https://510kreport.com/device/K882974 · printed Nov 6, 2026

Cite this page

510(k) Report. “K882974: Force Guard I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K882974

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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