510(k) Report

510(k) · Cleared

Cleared

Acromed Awl/Punch, Depth Gauge

K880045510(k) TraditionalCleared Feb 17, 198842-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

Buckman Co., Inc. · HWJ Awl

Cleared on Feb 17, 1988 after a 42-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Feb 17, 1988
Review
42 days
Class
Class I
Product code
HWJ
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K880045Source: 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.

Planning a device in HWJ? 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?

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 HWJ devices

HWJ Awl: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HWJ

FDA has decided no HWJ device since 2007.

Median 510(k) review, days · HWJ

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

Recalls per year · HWJ

No recall names HWJ since 2007.

Adverse event reports per year · HWJ

17in 2025

2007: 162008: 172009: 252010: 92011: 32012: 92013: 322014: 162015: 182016: 242017: 122018: 112019: 172020: 92021: 92022: 102023: 92024: 172025: 17
2007high 32 (2013) · low 3 (2011)2025

MAUDE reports naming product code HWJ, 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—016
20080—017
20090—025
20100—09
20110—03
20120—09
20130—032
20140—016
20150—018
20160—024
20170—012
20180—011
20190—017
20200—09
20210—09
20220—010
20230—09
20240—017
20250—017
20260—0—

More from Buckman Co., Inc.

111 FDA decisions under this applicant name. See the company

  • K961320Cross Medical Bone Plate System/ CM Bone Plate System/Cross TI Bone Plate SystemBuckman Co., Inc. · 1998
  • K974641Futurelase 3000/3002 Erbium Laser SystemBuckman Co., Inc. · 1998
  • K964252OrthochuckBuckman Co., Inc. · 1997
  • K950099Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
  • K960451Webb-Morley Spine SystemBuckman Co., Inc. · 1996

Recent decisions in HWJ

The HWJ category page

  • K895587Cross Medical Product Pedicle AwlCross Medical Products, Inc. · 1990
  • K875223Danninger Orthopaedic AwlDanninger Medical Technology, Inc. · 1988
  • K870779Acromed Wallie-Heinig TrocharBuckman Co., Inc. · 1987

https://510kreport.com/device/K880045 · printed Nov 4, 2026

Cite this page

510(k) Report. “K880045: Acromed Awl/Punch, Depth Gauge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K880045

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