510(k) · Cleared

Cleared

Sorbitol Macconkey (Smac) Agar, Dri & Pre-Form

K871855510(k) TraditionalCleared May 26, 198713-day reviewClass I21 CFR 866.2320

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

Gibco Laboratories Life Technologies, Inc. · JSH Culture Media, Non-Selective And Differential

Cleared on May 26, 1987 after a 13-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: May 26, 1987
Review: 13 days
Class: Class I
Product code: JSH
Recalls: None
Predicates: 0

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

This deviceK871855 Sorbitol Macconkey (Smac) Agar, Dri & Pre-FormGibco Laboratories Life Technologies, Inc. · 1987
Descendant · cites it directly · 0 of its ownK070691 BBL Chromagar 0157Becton, Dickinson & CO · 2007

Most influential descendants

Showing 1 of 1 · See all

K070691BBL Chromagar 0157Becton, Dickinson & CO · 2007 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K871855	Sorbitol Macconkey (Smac) Agar, Dri & Pre-Form	Gibco Laboratories Life Technologies, Inc.	1987	—
+1	K070691	BBL Chromagar 0157	Becton, Dickinson & CO	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0

FIG. 1 — Lineage of K871855, 1987–2007Source: 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.

Planning a device in JSH? 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.

Number	Device	Applicant	Decided	Descendants
K070691	BBL Chromagar 0157	Becton, Dickinson & CO	2007	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, K070691 (Becton, Dickinson & CO, 2007) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JSH devices

JSH Culture Media, Non-Selective And Differential: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JSH

FDA has decided no JSH device since 2007.

Median 510(k) review, days · JSH

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

Recalls per year · JSH

No recall names JSH since 2007.

Adverse event reports per year · JSH

20in 2025

2007high 42 (2021) · low 0 (2008)2025

MAUDE reports naming product code JSH, 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	—	1
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	1
2018	—	0
2019	—	0
2020	—	0
2021	—	42
2022	—	10
2023	—	8
2024	—	11
2025	—	20
2026	—	—

https://510kreport.com/device/K871855 · printed Nov 5, 2026

Cite this page

510(k) Report. “K871855: Sorbitol Macconkey (Smac) Agar, Dri & Pre-Form.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K871855

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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