Cleared Traditional

K884167 - TECH MED NITROUS OXIDE SEDATION NASAL INHALER CIR.

K884167 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 24-day FDA review.

K884167 · Technical Medical Products, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1988
Decision
24d
Days
Class 2
Risk

K884167 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 October 28, 1988 after a review of 24 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 - K884167

510(k) Number K884167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1988
Decision Date October 28, 1988
Days to Decision 24 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
116d faster than avg
Panel avg: 140d · This submission: 24d
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 K884167.
TECH MED NITROUS OXIDE SEDATION NASAL INHALER CIR.
K896510 · Technical Medical Products, Inc. · Jan 1990
RESUBMITTED RADIOAEROSOL CONT. SYSTEM MP-963
K893532 · Medipart Jerry Alexander · Aug 1989
GAS-VAK(R), MODEL 300
K890438 · Gas-Vak · Aug 1989
OPEN RESERVOIR SCAVENGER
K864034 · Draeger Medical, Inc. · Dec 1986
DEMAND FLOW VALVE & SONRA W/NASAL MASK
K854571 · Gale E. Dryden · Feb 1986
GAS EVACUATION ACCESSORY
K852772 · Siemens Elema AB · Oct 1985
K884167 · TECH MED NITROUS OXIDE SEDATION NASAL INHALER CIR.
Download PDF Technical Medical Pro…