510(k) Report

510(k) · Cleared

Cleared

Splint, Bohler

K770612510(k) TraditionalCleared Apr 8, 19778-day reviewClass I21 CFR 890.3475

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

Will Ross Co. · IQI Orthosis, Limb Brace

Cleared on Apr 8, 1977 after an 8-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Apr 8, 1977
Review
8 days
Class
Class I
Product code
IQI
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K770612Source: 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 IQI? 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 IQI devices

IQI Orthosis, Limb Brace: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IQI

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IQI

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

Recalls per year · IQI

3in 2023

2016: 22018: 22023: 3
2007high 3 (2023) · low 0 (2007)2026

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

Adverse event reports per year · IQI

8in 2025

2007: 52008: 122009: 332010: 122011: 162012: 312013: 362014: 392015: 202016: 142017: 932018: 192019: 192020: 112021: 92022: 112023: 32024: 22025: 8
2007high 93 (2017) · low 2 (2024)2025

MAUDE reports naming product code IQI, 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—05
20080—012
20090—033
20100—012
20110—016
20120—031
20130—036
20140—039
20151—020
20160—214
20170—093
20180—219
20190—019
20200—011
20210—09
20220—011
20230—33
20240—02
20250—08
20260—0—

More from Will Ross Co.

14 FDA decisions under this applicant name. See the company

  • K780850Searle Neonatal Oxygen ProbeWill Ross Co. · 1978
  • K771561Dover Urine MeterWill Ross Co. · 1977
  • K771132Kenwood Biological Steoiliz. IndicatorWill Ross Co. · 1977
  • K770608Walking AidWill Ross Co. · 1977
  • K770611Parallel BarsWill Ross Co. · 1977

Recent decisions in IQI

The IQI category page

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  • K031576Spartan Orthopaedic Wrist Brace, Model SCT-1Surgitech, Inc. · 2003
  • K926391Accuflex Dynamic Elbow OrthosisRegulatory & Marketing Services, Inc. · 1993
  • K910974Mcconnell Shoulder BraceMcconnell Orthopedic · 1991

https://510kreport.com/device/K770612 · printed Nov 4, 2026

Cite this page

510(k) Report. “K770612: Splint, Bohler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K770612

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