Sickle-Stat Hemoglobin S Screen Kit

K841272510(k) TraditionalCleared Apr 13, 198417-day reviewClass II21 CFR 864.7825Recalls 1

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

Clinical Technology Corp. · GHM Test, Sickle Cell

Cleared on Apr 13, 1984 after a 17-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled once.

Decided: Apr 13, 1984
Review: 17 days
Class: Class II
Product code: GHM
Recalls: 1
Predicates: 0

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

FIG. 1 — Lineage of K841272Source: 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.

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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)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 16, 2005	Not classified	Z-0470-06	Other	Firm received one report of a false negative with the positive control. Internal testing by the firm has shown that the kit lot may result in invalid or false negative interpretations.

No ancestor or descendant has a Class I recall.

How does its category compare?

All GHM devices

GHM Test, Sickle Cell: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GHM

FDA has decided no GHM device since 2007.

Median 510(k) review, days · GHM

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

Recalls per year · GHM

3in 2012

2007high 3 (2012) · low 0 (2007)2026

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

Adverse event reports per year · GHM

No MAUDE report names GHM since 2007.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	0
2009	—	0	0
2010	—	0	0
2011	—	0	0
2012	—	3	0
2013	—	0	0
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	0	0
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	0	0
2024	—	0	0
2025	—	0	0
2026	—	0	—

https://510kreport.com/device/K841272 · printed Nov 5, 2026

Cite this page

510(k) Report. “K841272: Sickle-Stat Hemoglobin S Screen Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K841272

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Record history

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