510(k) Report

510(k) · Cleared

Cleared

Bremer Imaging Tongs-Mri Model

K924606510(k) TraditionalCleared Sep 9, 1993363-day reviewClass II21 CFR 882.5960

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

Bremer Medical, Inc. · HAX Tong, Skull For Traction

Cleared on Sep 9, 1993 after a 363-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Sep 9, 1993
Review
363 days
Class
Class II
Product code
HAX
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared1990200020102020
  1. This deviceK924606 Bremer Imaging Tongs-Mri ModelBremer Medical, Inc. · 1993
  2. Descendant · cites it directly · 0 of its ownK980689 Friddle Halo System, Friddle Mri Halo SystemFriddle'S Orthopedic Appliances, Inc. · 1999

Most influential descendants

Showing 1 of 1 · See all
  • K980689Friddle Halo System, Friddle Mri Halo SystemFriddle'S Orthopedic Appliances, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K924606Bremer Imaging Tongs-Mri ModelBremer Medical, Inc.1993—
+1K980689Friddle Halo System, Friddle Mri Halo SystemFriddle'S Orthopedic Appliances, Inc.1999—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
FIG. 1 — Lineage of K924606, 1993–1999Source: FDA 510(k) summaries, read by 510(k) Report · 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 HAX? 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? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K980689Friddle Halo System, Friddle Mri Halo SystemFriddle'S Orthopedic Appliances, Inc.19990

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.

What does this lineage say?

  • Of its descendants, K980689 (Friddle'S Orthopedic Appliances, Inc., 1999) has gone furthest, with 0 descendants of its own.

How does its category compare?

All HAX devices

HAX Tong, Skull For Traction: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HAX

1in 2009

2007: 12009: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HAX

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

Recalls per year · HAX

4in 2018

2008: 32014: 62018: 4
2007high 6 (2014) · low 0 (2007)2026

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

Adverse event reports per year · HAX

1in 2020

2008: 12010: 12011: 22015: 12016: 12017: 12020: 1
2007high 2 (2011) · low 0 (2007)2025

MAUDE reports naming product code HAX, 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
20071—00
20080—31
20091—00
20100—01
20110—02
20120—00
20130—00
20140—60
20150—01
20160—01
20170—01
20180—40
20190—00
20200—01
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Bremer Medical, Inc.

2 FDA decisions under this applicant name. See the company

  • K915800Bremer Halo System Cervical Traction Skull PinBremer Medical, Inc. · 199215 recalls

Recent decisions in HAX

The HAX category page

  • K090733PMT Halo SystemPmt Corp. · 2009
  • K071173Resolve Tongs, Small/Medium, Resolve Tongs, Medium/Large, Model JT-200D, JT-100DOssur Americans (Formerly the Jerome Group) · 2007
  • K051918Resolve Open Back Halo RingsJerome Medical · 20057 recalls
  • K023959Jerome Glass RingThe Jerome Group, Inc. · 20036 recalls
  • K003662Spine Works CollarSpine Works · 2001

https://510kreport.com/device/K924606 · printed Nov 6, 2026

Cite this page

510(k) Report. “K924606: Bremer Imaging Tongs-Mri Model.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K924606

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