Cleared Traditional

K915848 - SENSORMEDICS MODEL 2450 PULMONARY FUNCTION LAB. (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K915848 · Sensor Medics Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1992
Decision
307d
Days
Class 2
Risk

K915848 is an FDA 510(k) clearance for the SENSORMEDICS MODEL 2450 PULMONARY FUNCTION LAB.. Classified as Driver, Wire, And Bone Drill, Manual (product code DZJ), Class II - Special Controls.

Submitted by Sensor Medics Corp. (Yorba Linda, US). The FDA issued a Cleared decision on October 28, 1992 after a review of 307 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4120 - the FDA dental device regulatory 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 Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Sensor Medics Corp. devices

Submission Details

510(k) Number K915848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1991
Decision Date October 28, 1992
Days to Decision 307 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
180d slower than avg
Panel avg: 127d · This submission: 307d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DZJ Driver, Wire, And Bone Drill, Manual
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4120
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 Dental devices follow this clearance model.

Regulatory Peers - DZJ Driver, Wire, And Bone Drill, Manual

All 30
Devices cleared under the same product code (DZJ) and FDA review panel - the closest regulatory comparables to K915848.
Materialise Personalized Guides and Models for Craniomaxillofacial Surgery
K243637 · Materialise NV · Feb 2025
TECHFIT DISRP® System
K242263 · Techfit Digital Surgery, Inc. · Dec 2024
tmCMF Solution
K231520 · Techmah Cmf · Oct 2023
TECHFIT DISRP® System
K230276 · Techfit Digital Surgery · Jun 2023
MedCAD AccuPlan System
K223024 · Medcad · Mar 2023
EmbedMed
K220366 · 3D Lifeprints UK , Ltd. · Sep 2022