Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

Ophthalmic Spatula

Model K3-2329 · KATENA PRODUCTS, INC. · DI 00841668102435

HND — Spatula, Ophthalmic · Class I · 21 CFR 886.4350

UDILibrary device dossier · generated 2026-09-11 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (1)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

Malfunction: 1

12232019-10: 0 reports for this device; peer average 3/device2021-04: 0 reports for this device; peer average 1/device2021-09: 0 reports for this device; peer average 1/device2022-09: 1 reports for this device; peer average 1/device2024-01: 0 reports for this device; peer average 1/device2025-05: 0 reports for this device; peer average 3/device2025-09: 0 reports for this device; peer average 1/device2026-04: 0 reports for this device; peer average 2/device1004090901050904
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-1003
2021-0401
2021-0901
2022-0911
2024-0101
2025-0503
2025-0901
2026-0402
This device (reports/month)Average device in HND (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — KATENA PRODUCTS, INC.

  • NAI 2016-08-31 Katena Products, Inc. · 0 citations
  • NAI 2014-04-21 Katena Products Inc. · 0 citations
  • NAI 2012-02-22 Katena Products, Inc. · 0 citations