510(k) Report

510(k) · Cleared

Cleared

Exel Indwelling Catheter

K895772510(k) TraditionalCleared Feb 16, 1990143-day reviewClass I21 CFR 876.1500

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

Exel Intl. · FDZ Attachment, Eyepiece, For Insertion Of Prescription Lens

Cleared on Feb 16, 1990 after a 143-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Feb 16, 1990
Review
143 days
Class
Class I
Product code
FDZ
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K895772Source: 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 FDZ? 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 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 FDZ devices

FDZ Attachment, Eyepiece, For Insertion Of Prescription Lens: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FDZ

FDA has decided no FDZ device since 2007.

Median 510(k) review, days · FDZ

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

Recalls per year · FDZ

No recall names FDZ since 2007.

Adverse event reports per year · FDZ

No MAUDE report names FDZ since 2007.

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—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Exel Intl.

18 FDA decisions under this applicant name. See the company

  • K992290Exel Injection Plug with CapExel Intl. · 2000
  • K963658Exel Avf Single NeedleExel Intl. · 1998
  • K963659Exel I.V. Administration SetExel Intl. · 1997
  • K926119Exel Huber Infusion Set Rotating WingExel Intl. · 1993
  • K904685Exel Huber Infusion Set Without Injection Site (Y)Exel Intl. · 1990

Recent decisions in FDZ

The FDZ category page

  • K852642Central Vein Catheterization TrayTeleflexmedical, Inc. · 1986

https://510kreport.com/device/K895772 · printed Nov 6, 2026

Cite this page

510(k) Report. “K895772: Exel Indwelling Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K895772

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