Cleared Traditional

K811092 - STERILE PACKAGING

K811092 is an FDA 510(k) clearance for STERILE PACKAGING, manufactured by Telectronics, Inc.. The device is a Class 2 Cardiovascular device with product code DTE cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K811092 · Telectronics, Inc. · Cardiovascular device
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Jul 1981
Decision
71d
Days
Class 2
Risk

K811092 is an FDA 510(k) clearance for the STERILE PACKAGING. Classified as Pulse-generator, Pacemaker, External (product code DTE), Class II - Special Controls.

Submitted by Telectronics, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 1, 1981 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3600 - the FDA cardiovascular device oversight 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 Telectronics, Inc. devices

FDA 510(k) Submission Details - K811092

510(k) Number K811092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1981
Decision Date July 01, 1981
Days to Decision 71 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 125d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTE Device Classification - Class 2, Special Controls

Product Code DTE Pulse-generator, Pacemaker, External
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3600
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DTE Pulse-generator, Pacemaker, External

All 28
Devices cleared under the same product code (DTE) and FDA review panel - the closest regulatory comparables to K811092.
MODEL 5330 EXTERNAL A-V SEQUENTIAL DEMAND PULSE
K893633 · Medtronic Vascular · Jun 1989
ERA-20
K853194 · Biotronik Sales, Inc. · Mar 1987
EXTERNAL PULSE GENERATOR FOR TEMP. STIM
K831768 · Oscor, Inc. · Dec 1983
PACING SYSTEM ANALYZER
K803313 · Medtronic Vascular · Feb 1981
CHRONOCOR IV MODEL 250
K802221 · Cordis Corp. · Nov 1980
COMPUPACE, 524-01 PACER SYSTEM COMPUTER
K801055 · Intermedics, Inc. · Oct 1980