Cleared Traditional

K881293 - SHERIDAN ELECTROSURGERY PROTECTION FILTER

K881293 is an FDA 510(k) clearance for SHERIDAN ELECTROSURGERY PROTECTION FILTER, manufactured by Sheridan Catheter Corp.. The device is a Class 2 Anesthesiology device with product code BZT cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K881293 · Sheridan Catheter Corp. · Anesthesiology device
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Jun 1988
Decision
80d
Days
Class 2
Risk

K881293 is an FDA 510(k) clearance for the SHERIDAN ELECTROSURGERY PROTECTION FILTER. Classified as Stethoscope, Esophageal, With Electrical Conductors (product code BZT), Class II - Special Controls.

Submitted by Sheridan Catheter Corp. (Argyle, US). The FDA issued a Cleared decision on June 16, 1988 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1920 - 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.

View all Sheridan Catheter Corp. devices

FDA 510(k) Submission Details - K881293

510(k) Number K881293 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1988
Decision Date June 16, 1988
Days to Decision 80 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
60d faster than avg
Panel avg: 140d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZT Device Classification - Class 2, Special Controls

Product Code BZT Stethoscope, Esophageal, With Electrical Conductors
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1920
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 - BZT Stethoscope, Esophageal, With Electrical Conductors

All 21
Devices cleared under the same product code (BZT) and FDA review panel - the closest regulatory comparables to K881293.
YSI MODEL 441A AIRWAY TEMPERATURE PROBE
K922007 · Yellow Springs Instrument Co., Inc. · Nov 1992
YSI MODELS 4400 & 4700 ESOPHAGEAL STETHOSCOPE TEMP
K893409 · Yellow Springs Instrument Co., Inc. · Jul 1989
TELEMETRIC STETHOSCOPE
K882319 · Vital Signs, Inc. · Aug 1988
ESOPHAGEAL STETHOSCOPE W/ELECTRICAL CONDUCTORS
K874295 · Sheridan Catheter Corp. · Nov 1987
ESOPHAGEAL STETHOSCOPE W/THERMISTOR
K873344 · Medical Components, Inc. · Oct 1987
ESOPHAGEAL STETHOSCOPE W/THERMOCOUPLE TYPE T
K864043 · Respiratory Support Products, Inc. · Dec 1986