510(k) Report

510(k) · Cleared

Cleared

Iafp Mac Conkey Agar

K872670510(k) TraditionalCleared Aug 11, 198735-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

I.A.F. Production, Inc. · JSH Culture Media, Non-Selective And Differential

Cleared on Aug 11, 1987 after a 35-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Aug 11, 1987
Review
35 days
Class
Class I
Product code
JSH
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K872670Source: 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 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?

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 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

2007: 12017: 12021: 422022: 102023: 82024: 112025: 20
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—01
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—01
20180—00
20190—00
20200—00
20210—042
20220—010
20230—08
20240—011
20250—020
20260—0—

More from I.A.F. Production, Inc.

29 FDA decisions under this applicant name. See the company

  • K872690Iafp V. Agar SelectiveI.A.F. Production, Inc. · 1987
  • K872669Iafp X.L.D. AgarI.A.F. Production, Inc. · 1987
  • K872681Iafp C.D.C. Anaerobic Agar W/5% Sheep BloodI.A.F. Production, Inc. · 1987
  • K872691Iafp Urea Agar SlantI.A.F. Production, Inc. · 1987
  • K872688Iafp Mueller Hinton Agar W/5% Sheep BloodI.A.F. Production, Inc. · 1987

Recent decisions in JSH

The JSH category page

  • K881551Phenol Red Broth BaseAcumedia Manufacturers, Inc. · 1988
  • K881486Dnase Test AgarAcumedia Manufacturers, Inc. · 1988
  • K881553Russell Double Sugar AgarAcumedia Manufacturers, Inc. · 1988
  • K881559Urea Agar BaseAcumedia Manufacturers, Inc. · 1988
  • K881540Flo AgarAcumedia Manufacturers, Inc. · 1988

https://510kreport.com/device/K872670 · printed Nov 4, 2026

Cite this page

510(k) Report. “K872670: Iafp Mac Conkey Agar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K872670

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