510(k) Report

510(k) · Cleared

Cleared

Flat Wrench

K781451510(k) TraditionalCleared Sep 27, 197835-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

Orthopedic Equipment Co., Inc. · HXS Twister, Wire

Cleared on Sep 27, 1978 after a 35-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Sep 27, 1978
Review
35 days
Class
Class I
Product code
HXS
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K781451Source: FDA 510(k) database · 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 HXS? 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
Get a 510(k) Report

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 HXS devices

HXS Twister, Wire: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HXS

FDA has decided no HXS device since 2007.

Median 510(k) review, days · HXS

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

Recalls per year · HXS

1in 2012

2010: 12012: 1
2007high 1 (2010) · low 0 (2007)2026

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

Adverse event reports per year · HXS

1in 2025

2010: 12012: 32013: 12016: 12021: 12022: 32025: 1
2007high 3 (2012) · low 0 (2007)2025

MAUDE reports naming product code HXS, 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—00
20080—00
20090—00
20100—11
20110—00
20120—13
20130—01
20140—00
20150—00
20160—01
20170—00
20180—00
20190—00
20200—00
20210—01
20220—03
20230—00
20240—00
20250—01
20260—0—

More from Orthopedic Equipment Co., Inc.

45 FDA decisions under this applicant name. See the company

  • K834035Universal Self-Aligning Acetabular ComOrthopedic Equipment Co., Inc. · 1984
  • K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  • K800530Schlein Tri-Surface AnkleOrthopedic Equipment Co., Inc. · 1980
  • K781445SpreaderOrthopedic Equipment Co., Inc. · 1979
  • K790247Tourniquet Test GageOrthopedic Equipment Co., Inc. · 1979

Recent decisions in HXS

The HXS category page

  • K833726Klein Wire Tightener/Bionic WireBionic Instrument Corp. · 1983

https://510kreport.com/device/K781451 · printed Nov 6, 2026

Cite this page

510(k) Report. “K781451: Flat Wrench.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K781451

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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