510(k) Report

510(k) · Cleared

Cleared

Toggle Locking Pliers-Straight Jaw, Curved Jaw

K844146510(k) TraditionalCleared Nov 20, 198428-day reviewClass I21 CFR 878.4800

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

Med-Tool, Inc. · HTC Pliers, Surgical

Cleared on Nov 20, 1984 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Nov 20, 1984
Review
28 days
Class
Class I
Product code
HTC
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K844146Source: 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 HTC? 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 HTC devices

HTC Pliers, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HTC

FDA has decided no HTC device since 2007.

Median 510(k) review, days · HTC

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

Recalls per year · HTC

3in 2014

2009: 12014: 3
2007high 3 (2014) · low 0 (2007)2026

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

Adverse event reports per year · HTC

27in 2025

2010: 22011: 12012: 32013: 872014: 382015: 312016: 532017: 212018: 162019: 232020: 252021: 182022: 222023: 82024: 252025: 27
2007high 87 (2013) · low 0 (2007)2025

MAUDE reports naming product code HTC, 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—10
20100—02
20110—01
20120—03
20130—087
20140—338
20150—031
20160—053
20170—021
20180—016
20190—023
20200—025
20210—018
20220—022
20230—08
20240—025
20250—027
20260—0—

More from Med-Tool, Inc.

28 FDA decisions under this applicant name. See the company

  • K874357Tapered PunchMed-Tool, Inc. · 1987
  • K874359Adjustable WrenchesMed-Tool, Inc. · 1987
  • K874358Combination WrenchesMed-Tool, Inc. · 1987
  • K874356Pin PunchMed-Tool, Inc. · 1987
  • K872388Nail SetMed-Tool, Inc. · 1987

Recent decisions in HTC

The HTC category page

  • K872384Side Cutting Parallel Action PliersMed-Tool, Inc. · 1987
  • K864019Needle Nose PliersMed-Tool, Inc. · 1986
  • K861953Parallel Action PliersMed-Tool, Inc. · 1986
  • K854390Wire Cutting Pliers or Lineman's PliersMed-Tool, Inc. · 1985
  • K844600Slip Joint PliersMed-Tool, Inc. · 1984

https://510kreport.com/device/K844146 · printed Nov 4, 2026

Cite this page

510(k) Report. “K844146: Toggle Locking Pliers-Straight Jaw, Curved Jaw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K844146

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