510(k) Report

510(k) · Cleared

Cleared

Auramine O Mycrobacterial Stain Set

K812274510(k) TraditionalCleared Sep 1, 198119-day reviewClass I21 CFR 864.1850

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

Carr-Scarborough Microbiologicals, Inc. · KJK Auramine O

Cleared on Sep 1, 1981 after a 19-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Sep 1, 1981
Review
19 days
Class
Class I
Product code
KJK
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K812274Source: 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 KJK? 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 KJK devices

KJK Auramine O: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KJK

FDA has decided no KJK device since 2007.

Median 510(k) review, days · KJK

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

Recalls per year · KJK

No recall names KJK since 2007.

Adverse event reports per year · KJK

1in 2024

2021: 22024: 1
2007high 2 (2021) · low 0 (2007)2025

MAUDE reports naming product code KJK, 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—00
20190—00
20200—00
20210—02
20220—00
20230—00
20240—01
20250—00
20260—0—

More from Carr-Scarborough Microbiologicals, Inc.

24 FDA decisions under this applicant name. See the company

  • K944554Brain Heart Infusion AgarCarr-Scarborough Microbiologicals, Inc. · 1994
  • K941985Mueller Hinton Agar W/OxacillinCarr-Scarborough Microbiologicals, Inc. · 1994
  • K905472Lap DiscsCarr-Scarborough Microbiologicals, Inc. · 1991
  • K905666M. Cat. Butyrate DiscCarr-Scarborough Microbiologicals, Inc. · 1991
  • K891476C. Albicans ScreenCarr-Scarborough Microbiologicals, Inc. · 1989

Recent decisions in KJK

The KJK category page

  • K853081Auramine O Fluorescent Mycobacterial Stain SetAdvanced Medical Technology, Inc. · 1985

https://510kreport.com/device/K812274 · printed Nov 5, 2026

Cite this page

510(k) Report. “K812274: Auramine O Mycrobacterial Stain Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K812274

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