Cleared Traditional

K902881 - LAB-SITE SAFETY NEEDLE

K902881 is an FDA 510(k) clearance for LAB-SITE SAFETY NEEDLE, manufactured by Migada, Ltd.. The device is a Class 1 Anesthesiology device with product code CBT cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K902881 · Migada, Ltd. · Anesthesiology device
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Sep 1990
Decision
86d
Days
Class 1
Risk

K902881 is an FDA 510(k) clearance for the LAB-SITE SAFETY NEEDLE. Classified as Arterial Blood Sampling Kit (product code CBT), Class I - General Controls.

Submitted by Migada, Ltd. (Israel, IL). The FDA issued a Cleared decision on September 26, 1990 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1100 - the FDA anesthesiology and respiratory 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 Migada, Ltd. devices

FDA 510(k) Submission Details - K902881

510(k) Number K902881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1990
Decision Date September 26, 1990
Days to Decision 86 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 140d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

CBT Device Classification - Class 1, General Controls

Product Code CBT Arterial Blood Sampling Kit
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.1100
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CBT Arterial Blood Sampling Kit

All 40
Devices cleared under the same product code (CBT) and FDA review panel - the closest regulatory comparables to K902881.
DRI-VENDT/PROVENT/ACCUVENT ARTERIAL BLOOD GAS KITS
K930286 · Concord/Portex · Jun 1993
SHERWOOD MEDICAL ARTERIAL BLOOD GAS KIT II
K930471 · Sherwood Medical Co. · Jun 1993
ACCU-VENT(TM) WITH NEEDLE-PRO(TM)
K912043 · Concord/Portex · Jul 1991
GAS-LYTE 1CC AND 3CC ARTERIAL BLOOD SAMPLERS
K902632 · Marquest Medical Products, Inc. · Sep 1990
UMBILICAL CORD BLOOD SAMPLING KIT
K900302 · Ge Medical Systems Information Technologies · Apr 1990
MODEL 1050 - UMBILICAL CORD BLOOD SAMPLING KIT
K897133 · Transidyne General Corp. · Mar 1990