Cleared Traditional

K921288 - CURITY CALIBRATED TUOHY TYPE EPIDURAL N...

K921288 is an FDA 510(k) clearance for CURITY CALIBRATED TUOHY TYPE EPIDURAL N..., manufactured by Kendall Healthcare Products Co. Div.Of Tyco Health. The device is a Class 2 Anesthesiology device with product code BSP cleared through the Traditional 510(k) pathway after a 316-day FDA review.

K921288 · Kendall Healthcare Products Co. Div.Of Tyco Health · Anesthesiology device
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Jan 1993
Decision
316d
Days
Class 2
Risk

K921288 is an FDA 510(k) clearance for the CURITY CALIBRATED TUOHY TYPE EPIDURAL NEEDLE. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on January 27, 1993 after a review of 316 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Kendall Healthcare Products Co. Div.Of Tyco Health devices

FDA 510(k) Submission Details - K921288

510(k) Number K921288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1992
Decision Date January 27, 1993
Days to Decision 316 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
176d slower than avg
Panel avg: 140d · This submission: 316d
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 84
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K921288.
ESPOCAN COMBINED SPINAL/EPIDURAL NEEDLE SET & TRAY
K932400 · B. Braun of America, Inc. · Dec 1993
PAJUNK STANDARD SPROTTE NEEDLE W/ INTRODUCER CANN.
K923003 · Rusch, Inc. · Apr 1993
PHARMASEAL CLEAR HUB SPINAL NEEDLE
K920305 · Baxter Healthcare Corp · Jan 1993
ATRAUMATIC SPECIAL SPROTTE NEEDLE
K911221 · Pajunk GmbH · Jul 1992
ATRAUMATIC STANDARD SPROTTE NEEDLE
K911202 · Pajunk GmbH · May 1992
ATRAUMATIC STANDARD SPROTTE NEEDLE
K911260 · Pajunk GmbH · Oct 1991