Cleared Traditional

K791290 - BECKMAN B-4 TEB BUFFER KIT

K791290 is an FDA 510(k) clearance for BECKMAN B-4 TEB BUFFER KIT, manufactured by Beckman Instruments, Inc.. The device is a Class 2 Hematology device with product code JBD cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K791290 · Beckman Instruments, Inc. · Hematology device
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Aug 1979
Decision
24d
Days
Class 2
Risk

K791290 is an FDA 510(k) clearance for the BECKMAN B-4 TEB BUFFER KIT. Classified as System, Analysis, Electrophoretic Hemoglobin (product code JBD), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 3, 1979 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7440 - 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: 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 Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K791290

510(k) Number K791290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1979
Decision Date August 03, 1979
Days to Decision 24 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
89d faster than avg
Panel avg: 113d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JBD Device Classification - Class 2, Special Controls

Product Code JBD System, Analysis, Electrophoretic Hemoglobin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7440
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 - JBD System, Analysis, Electrophoretic Hemoglobin

All 20
Devices cleared under the same product code (JBD) and FDA review panel - the closest regulatory comparables to K791290.
A,A2 LYOPHILIZED HEMO CONTROL
K800854 · Helena Laboratories · Apr 1980
A,FSC LYOPHILIZED HEMO CONTROL
K800855 · Helena Laboratories · Apr 1980
A,FDA2 LYOPHILIZED HEMO CONTROL
K800856 · Helena Laboratories · Apr 1980
CITRATE AGAR GEL AND BUFFER SET
K790944 · Corning Medical & Scientific · Jun 1979
HBF-QUIPLATE METHODOLOGY
K780807 · Helena Laboratories · Jun 1978
REDI-DISC HEMOGLOBIN GEL TUBE KIT
K780163 · Miles Laboratories, Inc. · Mar 1978