Cleared Traditional

K821480 - RIGHT ATRIAL CATHETERS PARENTERAL NUTRIT

K821480 is an FDA 510(k) clearance for RIGHT ATRIAL CATHETERS PARENTERAL NUTRIT, manufactured by The Healthcare Group Laboratories, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K821480 · The Healthcare Group Laboratories, Inc. · Cardiovascular device
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Jun 1982
Decision
30d
Days
Class 2
Risk

K821480 is an FDA 510(k) clearance for the RIGHT ATRIAL CATHETERS PARENTERAL NUTRIT. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by The Healthcare Group Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 17, 1982 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight 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 The Healthcare Group Laboratories, Inc. devices

FDA 510(k) Submission Details - K821480

510(k) Number K821480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1982
Decision Date June 17, 1982
Days to Decision 30 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DQY Catheter, Percutaneous

All 619
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K821480.
CORONARY INFUSION CATHETER
K831717 · Advanced Cardiovascular Systems, Inc. · Jun 1983
INTRAOPERATIVE BALLOON DILATION CATH.
K822393 · Advanced Cardiovascular Systems, Inc. · Nov 1982
MULTIPURPOSE CATHETER
K821189 · Advanced Cardiovascular Systems, Inc. · Jul 1982
ARROW M.I.S. MULTI-LUMEN CATHETERIZA
K820648 · Arrow Intl., Inc. · Apr 1982
ARROW JUGULAR PUNCTURE KIT 16 GA.
K820009 · Arrow Intl., Inc. · Jan 1982
EDSLAB CATHETER COVER
K813514 · American Edwards Laboratories · Dec 1981