Cleared Traditional

K896510 - TECH MED NITROUS OXIDE SEDATION NASAL INHALER CIR.

K896510 is an FDA 510(k) clearance for TECH MED NITROUS OXIDE SEDATION NASAL I..., manufactured by Technical Medical Products, Inc.. The device is a Class 2 Anesthesiology device with product code CBN cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K896510 · Technical Medical Products, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1990
Decision
69d
Days
Class 2
Risk

K896510 is an FDA 510(k) clearance for the TECH MED NITROUS OXIDE SEDATION NASAL INHALER CIR.. Classified as Apparatus, Gas-scavenging (product code CBN), Class II - Special Controls.

Submitted by Technical Medical Products, Inc. (Phoenix, US). The FDA issued a Cleared decision on January 22, 1990 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5430 - 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.

FDA 510(k) Submission Details - K896510

510(k) Number K896510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1989
Decision Date January 22, 1990
Days to Decision 69 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
71d faster than avg
Panel avg: 140d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBN Device Classification - Class 2, Special Controls

Product Code CBN Apparatus, Gas-scavenging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5430
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 - CBN Apparatus, Gas-scavenging

All 42
Devices cleared under the same product code (CBN) and FDA review panel - the closest regulatory comparables to K896510.
AEROSTAR
K921313 · Biosafety Systems, Inc. · Sep 1992
CAP-EVAC ADAPTER
K904803 · Logan, Inc. · Nov 1990
DEMISTIFIER ISOLATION CHAMBER
K902161 · Peace Medical, Inc. · Oct 1990
RESUBMITTED RADIOAEROSOL CONT. SYSTEM MP-963
K893532 · Medipart Jerry Alexander · Aug 1989
GAS-VAK(R), MODEL 300
K890438 · Gas-Vak · Aug 1989
TECH MED NITROUS OXIDE SEDATION NASAL INHALER CIR.
K884167 · Technical Medical Products, Inc. · Oct 1988
K896510 · TECH MED NITROUS OXIDE SEDATION NASAL INHALER CIR.
Download PDF Technical Medical Pro…