510(k) Report

510(k) · Cleared

Cleared

Iafp V. Agar Selective

K872690510(k) TraditionalCleared Sep 14, 198769-day reviewClass I21 CFR 866.2360

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. · JSJ Culture Media, Selective And Non-Differential

Cleared on Sep 14, 1987 after a 69-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Sep 14, 1987
Review
69 days
Class
Class I
Product code
JSJ
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K872690Source: 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 JSJ? 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 JSJ devices

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

FDA decisions per year · JSJ

FDA has decided no JSJ device since 2007.

Median 510(k) review, days · JSJ

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

Recalls per year · JSJ

1in 2018

2018: 1
2007high 1 (2018) · low 0 (2007)2026

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

Adverse event reports per year · JSJ

337in 2025

2018: 22019: 102020: 62021: 462022: 562023: 162024: 192025: 337
2007high 337 (2025) · low 0 (2007)2025

MAUDE reports naming product code JSJ, 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—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—12
20190—010
20200—06
20210—046
20220—056
20230—016
20240—019
20250—0337
20260—0—

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

29 FDA decisions under this applicant name. See the company

  • K872681Iafp C.D.C. Anaerobic Agar W/5% Sheep BloodI.A.F. Production, Inc. · 1987
  • K872691Iafp Urea Agar SlantI.A.F. Production, Inc. · 1987
  • K872669Iafp X.L.D. AgarI.A.F. Production, Inc. · 1987
  • K872692Iafp P.E.a. Agar W/5% Sheep BloodI.A.F. Production, Inc. · 1987
  • K872670Iafp Mac Conkey AgarI.A.F. Production, Inc. · 1987

Recent decisions in JSJ

The JSJ category page

  • K882463Potato Dextrose Agar (Pda) - Product #P3421Lakewood Biochemical Co., Inc. · 1988
  • K881544Littman AgarAcumedia Manufacturers, Inc. · 1988
  • K881571YM BrothAcumedia Manufacturers, Inc. · 1988
  • K881570Sabouraud Maltose AgarAcumedia Manufacturers, Inc. · 1988
  • K881549Mycological Agar W/Low PHAcumedia Manufacturers, Inc. · 1988

https://510kreport.com/device/K872690 · printed Nov 4, 2026

Cite this page

510(k) Report. “K872690: Iafp V. Agar Selective.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K872690

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