Cleared Traditional

K894881 - 20GA X 7-1/2 THREADING BULLET POINT NEEDLE

K894881 is an FDA 510(k) clearance for 20GA X 7-1/2 THREADING BULLET POINT NEEDLE, manufactured by R. J. Doyle, Inc.. The device is a Class 2 Anesthesiology device with product code BSP cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K894881 · R. J. Doyle, Inc. · Anesthesiology device
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Nov 1989
Decision
121d
Days
Class 2
Risk

K894881 is an FDA 510(k) clearance for the 20GA X 7-1/2 THREADING BULLET POINT NEEDLE. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by R. J. Doyle, Inc. (Spirit Lake, US). The FDA issued a Cleared decision on November 30, 1989 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5150 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all R. J. Doyle, Inc. devices

FDA 510(k) Submission Details - K894881

510(k) Number K894881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1989
Decision Date November 30, 1989
Days to Decision 121 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 140d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSP Device Classification - Class 2, Special Controls

Product Code BSP Needle, Conduction, Anesthetic (w/wo Introducer)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5150
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - BSP Needle, Conduction, Anesthetic (w/wo Introducer)

All 117
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K894881.
ATRAUMATIC STANDARD SPROTTE NEEDLE
K911260 · Pajunk GmbH · Oct 1991
SPINAL TAP NEEDLE
K910652 · Gesco Intl., Inc. · Jul 1991
CURITY(R) CALIB TUOHY TYPE EPIDUR NEEDLE FIX WING
K910791 · Kendall Healthcare Products Co. Div.Of Tyco Health · May 1991
SPINAL NEEDLE
K895453 · Advance Medical Designs, Inc. · Oct 1989
TSK STERIJECT STERILE EPIDURAL NEEDLE
K854149 · Pharmacia, Inc. · Oct 1985
VYGON SPINAL ANESTHESIA NEEDLE W/INTRODUCER 183
K851478 · Vygon Corp. · May 1985