510(k) Report

510(k) · Cleared

Recalled · Class II · 2024

Bactidrop Acridine Orange

K920974510(k) TraditionalCleared Jun 19, 1992109-day reviewClass II21 CFR 862.1145Recalls 1

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

Remel Co. · JFO Fluorometric, Calcium

Cleared on Jun 19, 1992 after a 109-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. It has been recalled once.

Decided
Jun 19, 1992
Review
109 days
Class
Class II
Product code
JFO
Recalls
1
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K920974Source: 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 JFO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, 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)

Recalls of this device

DateClassRecallRoot causeReason
Sep 20, 2024Class IIZ-0266-2025Under Investigation by firmA color change of the solution within the dropper can occur from orange-yellow to light yellow resulting in out-of-specification fluorescent stain results.

No ancestor or descendant has a Class I recall.

How does its category compare?

All JFO devices

JFO Fluorometric, Calcium: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JFO

FDA has decided no JFO device since 2007.

Median 510(k) review, days · JFO

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

Recalls per year · JFO

1in 2024

2024: 1
2007high 1 (2024) · low 0 (2007)2026

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

Adverse event reports per year · JFO

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2025

MAUDE reports naming product code JFO, 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—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—10
20250—00
20260—0—

More from Remel Co.

137 FDA decisions under this applicant name. See the company

  • K013711Bacti-Swab DryRemel Co. · 2001
  • K965151A.C.T. IiiRemel Co. · 1997
  • K965149A.C.T. IRemel Co. · 1997
  • K965152A.C.T. IIRemel Co. · 19971 recall
  • K965150A.C.T. IVRemel Co. · 1997

https://510kreport.com/device/K920974 · printed Nov 5, 2026

Cite this page

510(k) Report. “K920974: Bactidrop Acridine Orange.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K920974

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