510(k) Report

510(k) · Cleared

Cleared

Slide Stainers GLS 360 & 360-1

K771714510(k) TraditionalCleared Oct 5, 197723-day reviewClass I21 CFR 864.3800

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

Honeywell, Inc. · KEY Stainer, Tissue, Automated

Cleared on Oct 5, 1977 after a 23-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Oct 5, 1977
Review
23 days
Class
Class I
Product code
KEY
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K771714Source: 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 KEY? 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 KEY devices

KEY Stainer, Tissue, Automated: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KEY

FDA has decided no KEY device since 2007.

Median 510(k) review, days · KEY

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

Recalls per year · KEY

1in 2009

2007: 22008: 22009: 1
2007high 2 (2007) · low 0 (2010)2026

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

Adverse event reports per year · KEY

1in 2023

2007: 12008: 32009: 22010: 42011: 32014: 52015: 12016: 22018: 22023: 1
2007high 5 (2014) · low 0 (2012)2025

MAUDE reports naming product code KEY, 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—21
20080—23
20090—12
20100—04
20110—03
20120—00
20130—00
20140—05
20150—01
20160—02
20170—00
20180—02
20190—00
20200—00
20210—00
20220—00
20230—01
20240—00
20250—00
20260—0—

More from Honeywell, Inc.

69 FDA decisions under this applicant name. See the company

  • K902230Colorado Color Imaging RecorderHoneywell, Inc. · 1990
  • K863100Cen Sta Mon AC/DC Alarm Central Acces Alarm RecorHoneywell, Inc. · 1987
  • K853501Honeywell Electronic Ventilator EV-aHoneywell, Inc. · 1986
  • K855125Physiological Telemetry Patient Monitoring SystemHoneywell, Inc. · 1986
  • K851888Apm Dispos. Blood Pressure TransducerHoneywell, Inc. · 1985

https://510kreport.com/device/K771714 · printed Nov 6, 2026

Cite this page

510(k) Report. “K771714: Slide Stainers GLS 360 & 360-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K771714

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