Cleared Traditional

K970997 - NEO-CARE LUMBER PUNCTURE KIT

K970997 is an FDA 510(k) clearance for NEO-CARE LUMBER PUNCTURE KIT, manufactured by Klein-Baker Medical, Inc.. The device is a Class 2 Anesthesiology device with product code MIA cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K970997 · Klein-Baker Medical, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
64d
Days
Class 2
Risk

K970997 is an FDA 510(k) clearance for the NEO-CARE LUMBER PUNCTURE KIT. Classified as Needle, Spinal, Short Term (product code MIA), Class II - Special Controls.

Submitted by Klein-Baker Medical, Inc. (San Antonio, US). The FDA issued a Cleared decision on May 22, 1997 after a review of 64 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 Klein-Baker Medical, Inc. devices

FDA 510(k) Submission Details - K970997

510(k) Number K970997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1997
Decision Date May 22, 1997
Days to Decision 64 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 140d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MIA Device Classification - Class 2, Special Controls

Product Code MIA Needle, Spinal, Short Term
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 - MIA Needle, Spinal, Short Term

Devices cleared under the same product code (MIA) and FDA review panel - the closest regulatory comparables to K970997.
Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors
K172800 · Smiths Medical Asd, Inc. · Jun 2018
CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND 27GA
K982269 · Allegiance Healthcare Corp. · Jul 1998
REGANES SPINAL NEEDLE (VARIOUS)
K971645 · Avid N.I.T., Inc. · Aug 1997
SPINAL NEEDLE
K960405 · Promex, Inc. · Feb 1996
ACUFEX T-FIX DELIVERY SYSTEM
K942442 · Acufex Microsurgical, Inc. · Dec 1994