Cleared Traditional

K921818 - ABBOTT SMART CAP

K921818 is an FDA 510(k) clearance for ABBOTT SMART CAP, manufactured by Abbott Laboratories. The device is a Class 2 Gastroenterology & Urology device with product code KDJ cleared through the Traditional 510(k) pathway after a 712-day FDA review.

K921818 · Abbott Laboratories · Gastroenterology & Urology device
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Mar 1994
Decision
712d
Days
Class 2
Risk

K921818 is an FDA 510(k) clearance for the ABBOTT SMART CAP. Classified as Set, Administration, For Peritoneal Dialysis, Disposable (product code KDJ), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on March 28, 1994 after a review of 712 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5630 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K921818

510(k) Number K921818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1992
Decision Date March 28, 1994
Days to Decision 712 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
582d slower than avg
Panel avg: 130d · This submission: 712d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KDJ Device Classification - Class 2, Special Controls

Product Code KDJ Set, Administration, For Peritoneal Dialysis, Disposable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5630
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KDJ Set, Administration, For Peritoneal Dialysis, Disposable

All 93
Devices cleared under the same product code (KDJ) and FDA review panel - the closest regulatory comparables to K921818.
HIGH DOSE DISCONNECT CAP AND MINICAP WITH POVIDONE-IODINE, HIGH DOSE DISCONNECT CAP WITH POVIDONE-IODINE
K972579 · Baxter Healthcare Corp · Oct 1997
ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493
K961825 · Baxter Healthcare Corp · Aug 1996
RAPID DISCONNECT Y-SET, CAT. NO. 48-7000
K930843 · National Medical Care, Medical Products Div., Inc. · Aug 1994
BAXTER APD 12' EXTENSION LINE
K925403 · Baxter Healthcare Corp · Feb 1994
FRESENIUS VARIABLE FILL MONITOR
K921052 · Fresenius USA, Inc. · Feb 1993
DEXTROLYTE II CAPD TRNSFER SET
K920029 · National Medical Care, Medical Products Div., Inc. · Sep 1992