Cleared Traditional

K820412 - AM. PH. STERILE PLASTIC CONNECTING TUBES

K820412 is an FDA 510(k) clearance for AM. PH. STERILE PLASTIC CONNECTING TUBES, manufactured by American Pharmaseal Div. Ahsc. The device is a Class 2 General Hospital device with product code BYY cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K820412 · American Pharmaseal Div. Ahsc · General Hospital
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Mar 1982
Decision
47d
Days
Class 2
Risk

K820412 is an FDA 510(k) clearance for the AM. PH. STERILE PLASTIC CONNECTING TUBES. Classified as Tube, Aspirating, Flexible, Connecting (product code BYY), Class II - Special Controls.

Submitted by American Pharmaseal Div. Ahsc (Mchenry, US). The FDA issued a Cleared decision on March 31, 1982 after a review of 47 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6740 - the FDA general hospital 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 Pharmaseal Div. Ahsc devices

FDA 510(k) Submission Details - K820412

510(k) Number K820412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1982
Decision Date March 31, 1982
Days to Decision 47 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 129d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BYY Device Classification - Class 2, Special Controls

Product Code BYY Tube, Aspirating, Flexible, Connecting
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6740
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 General Hospital devices follow this clearance model.

Regulatory Peers - BYY Tube, Aspirating, Flexible, Connecting

All 7
Devices cleared under the same product code (BYY) and FDA review panel - the closest regulatory comparables to K820412.
FLEX BUBBLE TUBING
K832865 · Sheridan Catheter Corp. · Sep 1983
DYNACOR CONNECTING TUBING
K832398 · Medline Industries, Inc. · Aug 1983
PLASTIC CONNECTORS
K820371 · American Pharmaseal Div. Ahsc · Apr 1982
ABCO CONNECTING TUBES PRECUT LENGTHS
K800235 · Abco Dealers, Inc. · Feb 1980
BUBBLE SUCTION TUBING
K780724 · Davol, Inc. · Jun 1978
FLEXIBLE TIP ASPIRATING TUBES
K761079 · Pilling Co. · Dec 1976