510(k) Report

510(k) · Cleared

Cleared

Holder, Needle

K890167510(k) TraditionalCleared Feb 3, 198925-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

Dhason Brothers, Inc. · HXK Holder, Needle; Orthopedic

Cleared on Feb 3, 1989 after a 25-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Feb 3, 1989
Review
25 days
Class
Class I
Product code
HXK
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K890167Source: 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 HXK? 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 HXK devices

HXK Holder, Needle; Orthopedic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HXK

FDA has decided no HXK device since 2007.

Median 510(k) review, days · HXK

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

Recalls per year · HXK

1in 2024

2011: 12024: 1
2007high 1 (2011) · low 0 (2007)2026

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

Adverse event reports per year · HXK

7in 2025

2007: 22008: 12010: 32011: 42012: 12013: 42014: 12015: 62016: 62017: 52018: 72019: 112020: 122021: 112022: 82023: 122024: 52025: 7
2007high 12 (2020) · low 0 (2009)2025

MAUDE reports naming product code HXK, 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—02
20080—01
20090—00
20100—03
20110—14
20120—01
20130—04
20140—01
20150—06
20160—06
20170—05
20180—07
20190—011
20200—012
20210—011
20220—08
20230—012
20240—15
20250—07
20260—0—

More from Dhason Brothers, Inc.

14 FDA decisions under this applicant name. See the company

  • K890161Thompson Type Rasp W/Tommy BarDhason Brothers, Inc. · 1989
  • K890160Gouges for Femoral HeadsDhason Brothers, Inc. · 1989
  • K890163Austin Moore Hallow ChiselDhason Brothers, Inc. · 1989
  • K890158RetractorsDhason Brothers, Inc. · 1989
  • K890165Forceps-OrthopedicDhason Brothers, Inc. · 1989

Recent decisions in HXK

The HXK category page

  • K872989Micrins Needle HolderMicrins Surgical, Inc. · 1987
  • K860018Fischer Wire/Pin ClampBuckman Co., Inc. · 19861 recall
  • K801594Ace Fischer External Fixation DeviceAce Orthopedic Manufacturing Co. · 1980
  • K772388Converse-Gillies Needle HolderEdward Weck, Inc. · 1978

https://510kreport.com/device/K890167 · printed Nov 4, 2026

Cite this page

510(k) Report. “K890167: Holder, Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K890167

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