510(k) Report

510(k) · Cleared

Cleared

AD Perfect

K940768510(k) TraditionalCleared Feb 17, 1995364-day reviewClass I21 CFR 864.4010

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

Chimera Research & Chemical, Inc. · IFT Glutaraldehyde

Cleared on Feb 17, 1995 after a 364-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Feb 17, 1995
Review
364 days
Class
Class I
Product code
IFT
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 K940768Source: 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 IFT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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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 IFT devices

IFT Glutaraldehyde: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IFT

FDA has decided no IFT device since 2007.

Median 510(k) review, days · IFT

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

Recalls per year · IFT

No recall names IFT since 2007.

Adverse event reports per year · IFT

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2025

MAUDE reports naming product code IFT, 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—01
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—00
20250—00
20260—0—

More from Chimera Research & Chemical, Inc.

7 FDA decisions under this applicant name. See the company

  • K970087CR PerfectChimera Research & Chemical, Inc. · 1997
  • K951877Automated Analysis Assay for Bilirubin in UrineChimera Research & Chemical, Inc. · 1996
  • K953393Tox Perfect a TubeChimera Research & Chemical, Inc. · 1995
  • K952501Tox Perfect B Tubes and ReagentsChimera Research & Chemical, Inc. · 1995
  • K950142CR PerfectChimera Research & Chemical, Inc. · 1995

https://510kreport.com/device/K940768 · printed Nov 6, 2026

Cite this page

510(k) Report. “K940768: AD Perfect.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K940768

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