Cleared Traditional

K822630 - MONOJECT PLASTIC HUB SPINAL NEEDLE

K822630 is the FDA 510(k) clearance for MONOJECT PLASTIC HUB SPINAL NEEDLE by Sherwood Medical Co.. It is a Class 2 Anesthesiology device (product code BSP) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K822630 · Sherwood Medical Co. · Anesthesiology device
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Oct 1982
Decision
34d
Days
Class 2
Risk

K822630 is an FDA 510(k) clearance for the MONOJECT PLASTIC HUB SPINAL NEEDLE. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Sherwood Medical Co. (Mchenry, US). The FDA issued a Cleared decision on October 4, 1982 after a review of 34 days - a notably fast clearance cycle.

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: 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 Sherwood Medical Co. devices

Submission Details

510(k) Number K822630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1982
Decision Date October 04, 1982
Days to Decision 34 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 140d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 64
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K822630.
TSK STERIJECT STERILE EPIDURAL NEEDLE
K854149 · Pharmacia, Inc. · Oct 1985
VYGON SPINAL ANESTHESIA NEEDLE W/INTRODUCER 183
K851478 · Vygon Corp. · May 1985
EPINEED EPIDURAL NEEDLE
K832233 · Terumo Medical Corp. · Aug 1983
SPINOCAN SPINAL NEEDLE
K820047 · Burron Medical Products, Inc. · Jan 1982
PLEXUFIX BRACHIAL PLEXUS ANESTH. NEEDLE
K813165 · Burron Medical Products, Inc. · Dec 1981
PERICAN, EPIDURAL CANNULA
K813179 · Burron Medical Products, Inc. · Dec 1981