Fracture Cast Brace Kit, Plastic

K770898510(k) TraditionalCleared Jul 21, 197766-day reviewClass I21 CFR 888.5890

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

Cleared on Jul 21, 1977 after a 66-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided: Jul 21, 1977
Review: 66 days
Class: Class I
Product code: HSP
Recalls: None
Predicates: 0

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

FIG. 1 — Lineage of K770898Source: FDA 510(k) database · How lineage is built

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 HSP? 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 HSP devices

HSP Splint, Traction: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HSP

FDA has decided no HSP device since 2007.

Median 510(k) review, days · HSP

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

Recalls per year · HSP

No recall names HSP since 2007.

Adverse event reports per year · HSP

1in 2016

2007high 1 (2014) · low 0 (2007)2025

MAUDE reports naming product code HSP, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	1
2015	—	0
2016	—	1
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/K770898 · printed Nov 3, 2026

Cite this page

510(k) Report. “K770898: Fracture Cast Brace Kit, Plastic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K770898

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Record history

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