510(k) Report

510(k) · Cleared

Cleared

Soft Tissue Expander

K923381510(k) TraditionalCleared May 5, 1993300-day reviewClass I21 CFR 888.4540

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

Acufex Microsurgical, Inc. · HWQ Passer

Cleared on May 5, 1993 after a 300-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
May 5, 1993
Review
300 days
Class
Class I
Product code
HWQ
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 K923381Source: 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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  • 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 HWQ devices

HWQ Passer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HWQ

FDA has decided no HWQ device since 2007.

Median 510(k) review, days · HWQ

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

Recalls per year · HWQ

2in 2015

2010: 12014: 22015: 2
2007high 2 (2014) · low 0 (2007)2026

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

Adverse event reports per year · HWQ

67in 2025

2007: 72008: 72009: 32010: 22011: 302012: 92013: 92014: 102015: 142016: 282017: 392018: 642019: 552020: 1712021: 1602022: 632023: 602024: 502025: 67
2007high 171 (2020) · low 2 (2010)2025

MAUDE reports naming product code HWQ, 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—07
20080—07
20090—03
20100—12
20110—030
20120—09
20130—09
20140—210
20150—214
20160—028
20170—039
20180—064
20190—055
20200—0171
20210—0160
20220—063
20230—060
20240—050
20250—067
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 HWQ

The HWQ category page

  • K970360Mitek Suture RetrograderMitek Products · 1997
  • K920621Acufex Passing Pins and Surgical WireAcufex Microsurgical, Inc. · 1993
  • K885311Meniscus Mender II LoopInstrument Makar, Inc. · 1989
  • K843592Vico Micro Surgical InstrumentsVisitec Co. · 1984
  • K841623Slotted Soft-Tissue InstrumentPlastafil, Inc. · 1984

https://510kreport.com/device/K923381 · printed Nov 6, 2026

Cite this page

510(k) Report. “K923381: Soft Tissue Expander.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K923381

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