510(k) Report

510(k) · Cleared

Cleared

Acufex Intra Articular Measuring Device

K925335510(k) TraditionalCleared Dec 29, 199268-day reviewClass I21 CFR 888.4300

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

Acufex Microsurgical, Inc. · HTJ Gauge, Depth

Cleared on Dec 29, 1992 after a 68-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Dec 29, 1992
Review
68 days
Class
Class I
Product code
HTJ
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K925335Source: FDA 510(k) database · 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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  • 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

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 HTJ devices

HTJ Gauge, Depth: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HTJ

FDA has decided no HTJ device since 2007.

Median 510(k) review, days · HTJ

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

Recalls per year · HTJ

1in 2011

2009: 12011: 1
2007high 1 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HTJ

401in 2025

2007: 12009: 12010: 52011: 22012: 62013: 1422014: 1062015: 1392016: 1782017: 822018: 1042019: 1962020: 3542021: 4032022: 3162023: 3762024: 3712025: 401
2007high 403 (2021) · low 0 (2008)2025

MAUDE reports naming product code HTJ, 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—01
20080—00
20090—11
20100—05
20110—12
20120—06
20130—0142
20140—0106
20150—0139
20160—0178
20170—082
20180—0104
20190—0196
20200—0354
20210—0403
20220—0316
20230—0376
20240—0371
20250—0401
20260—0—

More from Acufex Microsurgical, Inc.

78 FDA decisions under this applicant name. See the company

  • K961555Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
  • K961853Proline Fast Pass Arthoscopic Needle PasserAcufex Microsurgical, Inc. · 1996
  • K954246Acufex Endofix Absorbable Interference ScrewAcufex Microsurgical, Inc. · 1996
  • K952535Acufex Endobutton TapeAcufex Microsurgical, Inc. · 19962 recalls
  • K953276Acufex Tag Delivery SystemAcufex Microsurgical, Inc. · 1995

Recent decisions in HTJ

The HTJ category page

  • K940480Acufex Sub-Acromial Space Measuring DeviceAcufex Microsurgical, Inc. · 1994
  • K873191Acromed Interbody Depth GaugesBuckman Co., Inc. · 1987
  • K864426Raylor (TM) Depth GaugeCedar Surgical, Inc. · 1986

https://510kreport.com/device/K925335 · printed Nov 6, 2026

Cite this page

510(k) Report. “K925335: Acufex Intra Articular Measuring Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K925335

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