Cleared Traditional

K801082 - GAMBRO HEMOFREEZE-BAG

K801082 is an FDA 510(k) clearance for GAMBRO HEMOFREEZE-BAG, manufactured by Gambro, Inc.. The device is a Class 2 Hematology device with product code KSR cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K801082 · Gambro, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1980
Decision
177d
Days
Class 2
Risk

K801082 is an FDA 510(k) clearance for the GAMBRO HEMOFREEZE-BAG. Classified as Container, Empty, For Collection & Processing Of Blood & Blood Components (product code KSR), Class II - Special Controls.

Submitted by Gambro, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 31, 1980 after a review of 177 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.9100 - the FDA hematology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Gambro, Inc. devices

FDA 510(k) Submission Details - K801082

510(k) Number K801082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1980
Decision Date October 31, 1980
Days to Decision 177 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 113d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KSR Device Classification - Class 2, Special Controls

Product Code KSR Container, Empty, For Collection & Processing Of Blood & Blood Components
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.9100
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 Hematology devices follow this clearance model.

Regulatory Peers - KSR Container, Empty, For Collection & Processing Of Blood & Blood Components

All 8
Devices cleared under the same product code (KSR) and FDA review panel - the closest regulatory comparables to K801082.
HAEMONETICS 1000ML COMPONENT BAG
K811449 · Haemonetics Corp. · Jul 1981
HAEMONETICS 600 ML. COMPONENT BAG
K810711 · Haemonetics Corp. · May 1981
HAEMONETICS 1400 ML THERAPEUTIC BAG
K810313 · Haemonetics Corp. · Mar 1981
EMPTY TRANSFER BAG
K791673 · Delmed, Inc. · Oct 1979
TRANSFER PAK 4R 9006
K781811 · Travenol Laboratories, S.A. · Nov 1978
CRYOCYTE PACK
K780354 · Travenol Laboratories, S.A. · Jun 1978