Cleared Traditional

K822549 - CCPD CYCLER SET W/5 PRONGED SAFE LOCK

K822549 is an FDA 510(k) clearance for CCPD CYCLER SET W/5 PRONGED SAFE LOCK, manufactured by American Medical Products, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FKX cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K822549 · American Medical Products, Inc. · Gastroenterology & Urology device
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Oct 1982
Decision
50d
Days
Class 2
Risk

K822549 is an FDA 510(k) clearance for the CCPD CYCLER SET W/5 PRONGED SAFE LOCK. Classified as System, Peritoneal, Automatic Delivery (product code FKX), Class II - Special Controls.

Submitted by American Medical Products, Inc. (Freehold, US). The FDA issued a Cleared decision on October 13, 1982 after a review of 50 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all American Medical Products, Inc. devices

FDA 510(k) Submission Details - K822549

510(k) Number K822549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1982
Decision Date October 13, 1982
Days to Decision 50 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 131d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FKX Device Classification - Class 2, Special Controls

Product Code FKX System, Peritoneal, Automatic Delivery
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 - FKX System, Peritoneal, Automatic Delivery

All 64
Devices cleared under the same product code (FKX) and FDA review panel - the closest regulatory comparables to K822549.
CCPD CYCLER SET W/5 PRONGED CONNECTOR
K822545 · American Medical Products, Inc. · Oct 1982
SAFE LOCK SEALING CAPS
K822546 · American Medical Products, Inc. · Oct 1982
SAFE LOCK CATHETER S-3
K822548 · American Medical Products, Inc. · Oct 1982
SAFE LOCK TITANIUM ADAPTER SET
K822550 · American Medical Products, Inc. · Oct 1982
AUTOMATIC SPLICING DEVICE
K822025 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1982
CAPD BELT
K822547 · American Medical Products, Inc. · Sep 1982