510(k) Report

510(k) · Cleared

Cleared

Bactidrop India Ink

K920976510(k) TraditionalCleared Jun 9, 199299-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

Remel Co. · JTS Stains, Microbiologic

Cleared on Jun 9, 1992 after a 99-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Jun 9, 1992
Review
99 days
Class
Class I
Product code
JTS
Recalls
None
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 K920976Source: 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 JTS? 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 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)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All JTS devices

JTS Stains, Microbiologic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JTS

FDA has decided no JTS device since 2007.

Median 510(k) review, days · JTS

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

Recalls per year · JTS

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

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

Adverse event reports per year · JTS

101in 2025

2020: 1062021: 42023: 52024: 212025: 101
2007high 106 (2020) · low 0 (2007)2025

MAUDE reports naming product code JTS, 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—10
20150—00
20160—00
20170—00
20180—00
20190—00
20200—0106
20210—04
20220—00
20230—05
20240—021
20250—0101
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

Recent decisions in JTS

The JTS category page

  • K960095Bactidrop Calcofluor WhiteRemel Co. · 1996
  • K960090Calcofluor White Stain KitRemel Co. · 1996
  • K920975Bactidrop Calcofluor WhiteRemel Co. · 1992
  • K920970Bactidrop Koh (10%)Remel Co. · 1992
  • K893530Iristain Formula 2, Parts 1 and 2Intl. Remote Imaging Systems · 1989

https://510kreport.com/device/K920976 · printed Nov 4, 2026

Cite this page

510(k) Report. “K920976: Bactidrop India Ink.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K920976

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