Cleared Traditional

K915848 - SENSORMEDICS MODEL 2450 PULMONARY FUNCT...

K915848 is an FDA 510(k) clearance for SENSORMEDICS MODEL 2450 PULMONARY FUNCT..., manufactured by Sensor Medics Corp.. The device is a Class 2 Dental device with product code DZJ cleared through the Traditional 510(k) pathway after a 307-day FDA review.

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

FDA 510(k) Submission Details - K915848

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
Combination Product No
PCCP Authorized No
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.

DZJ Device Classification - Class 2, Special Controls

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.