Cleared Traditional

K172800 - Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors

K172800 is an FDA 510(k) clearance for Portex Lancet Point Spinal Needles with..., manufactured by Smiths Medical Asd, Inc.. The device is a Class 2 Anesthesiology device with product code MIA cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K172800 · Smiths Medical Asd, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2018
Decision
269d
Days
Class 2
Risk

K172800 is an FDA 510(k) clearance for the Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Po.... Classified as Needle, Spinal, Short Term (product code MIA), Class II - Special Controls.

Submitted by Smiths Medical Asd, Inc. (Plymouth, US). The FDA issued a Cleared decision on June 14, 2018 after a review of 269 days - an extended review 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: 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 Smiths Medical Asd, Inc. devices

FDA 510(k) Submission Details - K172800

510(k) Number K172800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2017
Decision Date June 14, 2018
Days to Decision 269 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
129d slower than avg
Panel avg: 140d · This submission: 269d
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

All 7
Devices cleared under the same product code (MIA) and FDA review panel - the closest regulatory comparables to K172800.
SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES
K983858 · Sims Portex, Inc. · Jan 1999
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
NEO-CARE LUMBER PUNCTURE KIT
K970997 · Klein-Baker Medical, Inc. · May 1997
GLOBAL MEDICAL PRODUCTS SPINAL,CONICAL TIP (SPROTTLE STYLE), WHITACRE STYLE NEEDLES
K961324 · Global Medical Prods, Inc. · Jul 1996
SPINAL NEEDLE
K960405 · Promex, Inc. · Feb 1996