510(k) · Cleared

Cleared

Rubascan Latex Card Test

K832228510(k) TraditionalCleared Sep 29, 198380-day reviewClass II21 CFR 866.3510

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

Bd Becton Dickinson Vacutainer Systems Preanalytic · GOK Antisera, Hai (Including Hai Control), Rubella

Cleared on Sep 29, 1983 after an 80-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 29, 1983
Review: 80 days
Class: Class II
Product code: GOK
Recalls: None
Predicates: 0

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

This deviceK832228 Rubascan Latex Card TestBd Becton Dickinson Vacutainer Systems Preanalytic · 1983
Descendant · cites it directly · 0 of its ownK952721 Rubascan Card TestBd Becton Dickinson Vacutainer Systems Preanalytic · 1996

Most influential descendants

Showing 1 of 1 · See all

K952721Rubascan Card TestBd Becton Dickinson Vacutainer Systems Preanalytic · 1996 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K832228	Rubascan Latex Card Test	Bd Becton Dickinson Vacutainer Systems Preanalytic	1983	—
+1	K952721	Rubascan Card Test	Bd Becton Dickinson Vacutainer Systems Preanalytic	1996	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0

FIG. 1 — Lineage of K832228, 1983–1996Source: FDA 510(k) summaries, read by 510(k) Report · 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? (1)

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

Number	Device	Applicant	Decided	Descendants
K952721	Rubascan Card Test	Bd Becton Dickinson Vacutainer Systems Preanalytic	1996	0

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, K952721 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1996) has gone furthest, with 0 descendants of its own.

How does its category compare?

All GOK devices

GOK Antisera, Hai (Including Hai Control), Rubella: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GOK

FDA has decided no GOK device since 2007.

Median 510(k) review, days · GOK

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

Recalls per year · GOK

No recall names GOK since 2007.

Adverse event reports per year · GOK

No MAUDE report names GOK since 2007.

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	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/K832228 · printed Nov 6, 2026

Cite this page

510(k) Report. “K832228: Rubascan Latex Card Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K832228

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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