Name: FDA 510(k) clearance K900106
Creator: U.S. Food and Drug Administration
Published: 1990-07-16

Clearance details

Applicant: Delmed, Inc.
Product code: Code KDJ
Device class: Class 2
Regulation: 21 CFR 876.5630
Advisory panel: Gastroenterology, Urology
Date received: 1990-01-09
Decision date: 1990-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Brunswick, NJ, US

Recent devices under product code KDJ

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K231849 — MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A +1 more2024-03-12
K214016 — 15L Cycler Drainage Bag2022-03-18
K192705 — MiniCap Extended Life PD Transfer Sets2019-10-25
K173593 — staysafe catheter extension set with Safe-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 6 inch, staysafe catheter extension set with Luer-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 18 inch, staysafe to Luer-Lock adapter, 4 inch2018-05-21

More clearances from Delmed, Inc.

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K895142 — ENTERAL PUMP SET WITH ENTERAL SPIKE1990-10-02
K895329 — 600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERA1990-10-02
K895650 — ENTERAL PUMP SET W/ENTERA-FLO SPIKE1990-10-02
K894506 — ENTERA-FLO ENTERAL FEEDING PUMP1990-08-06
K901477 — DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION1990-07-27

Adverse events under product code KDJ

product code KDJ

Death: 298
Injury: 9,221
Malfunction: 8,438
Other: 1
Total: 17,958

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →