510(k) Report

510(k) · Cleared

Cleared

Fujitens Iii

K893874510(k) TraditionalCleared Dec 22, 1989210-day reviewClass II21 CFR 882.4275

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

Altoona Medical Supply · GZQ Instrument, Dowel Cutting

Cleared on Dec 22, 1989 after a 210-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.

Decided
Dec 22, 1989
Review
210 days
Class
Class II
Product code
GZQ
Recalls
None
Predicates
0

9 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2002: 3 descendants cleared2003: 1 descendant cleared2000: 1 descendant cleared2009: 1 descendant cleared2017: 1 descendant cleared2022: 1 descendant cleared2026: 1 descendant cleared1990200020102020
  1. This deviceK893874 Fujitens IiiAltoona Medical Supply · 1989
  2. Descendant · cites it directly · 4 of its ownK022731 V Tens PlusBody Clock Health Care, Ltd. · 2002
  3. Descendant · 2 generations on · 3 of its ownK081835 Acticare IC and TseBioinduction Limited · 2009
  4. Descendant · 3 generations on · 2 of its ownK161091 STIMPOD NMS460 Nerve StimulatorXavant Technology (Pty), Ltd. · 2017
  5. Descendant · 4 generations on · 0 of its ownK252712 STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc. · 2026
  6. Descendant · 3 generations on · 0 of its ownK213802 StimOnTM Pain Relief System (GM2439)Gimer Medical Co., Ltd. · 2022

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2000: 12002: 32003: 12009: 12017: 12022: 12026: 1
2000high 3 (2002) · low 0 (2001)2026

Most influential descendants

Showing 5 of 9 · See all
  • K022731V Tens PlusBody Clock Health Care, Ltd. · 2002 · cites it directly4descendants
  • K081835Acticare IC and TseBioinduction Limited · 2009 · 2 generations on3descendants
  • K161091STIMPOD NMS460 Nerve StimulatorXavant Technology (Pty), Ltd. · 2017 · 3 generations on2descendants
  • K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc. · 2026 · 4 generations on0descendants
  • K213802StimOnTM Pain Relief System (GM2439)Gimer Medical Co., Ltd. · 2022 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K893874Fujitens IiiAltoona Medical Supply1989—
+1K022731V Tens PlusBody Clock Health Care, Ltd.2002—
+2K081835Acticare IC and TseBioinduction Limited2009—
+3K161091STIMPOD NMS460 Nerve StimulatorXavant Technology (Pty), Ltd.2017—
+4K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.2026—
+3K213802StimOnTM Pain Relief System (GM2439)Gimer Medical Co., Ltd.2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
200230
200310
200910
201710
202210
202610
FIG. 1 — Lineage of K893874, 1989–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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.

Planning a device in GZQ? 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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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? (9)

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

NumberDeviceApplicantDecidedDescendants
K022731V Tens PlusBody Clock Health Care, Ltd.20024
K022849Body Clock Tens N' ToneBody Clock Health Care, Ltd.20030
K021846804SIII; 804W; Libra Tens; 410; S-Tens IIBody Clock Health Care, Ltd.20020
K022076First Choice & First Choice PlusBody Clock Health Care, Ltd.20020
K984376ENDOR 2000T.C. Medical, Inc.20000

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, K022731 (Body Clock Health Care, Ltd., 2002) has gone furthest, with 4 descendants of its own.

How does its category compare?

All GZQ devices

GZQ Instrument, Dowel Cutting: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GZQ

FDA has decided no GZQ device since 2007.

Median 510(k) review, days · GZQ

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

Recalls per year · GZQ

No recall names GZQ since 2007.

Adverse event reports per year · GZQ

No MAUDE report names GZQ 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—

More from Altoona Medical Supply

3 FDA decisions under this applicant name. See the company

  • K921711Flexion Distration SupportAltoona Medical Supply · 1992
  • K913272EMS/400Altoona Medical Supply · 1991

https://510kreport.com/device/K893874 · printed Nov 4, 2026

Cite this page

510(k) Report. “K893874: Fujitens Iii.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K893874

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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