Cleared Traditional

K810410 - STERILE PACKAGING

K810410 is an FDA 510(k) clearance for STERILE PACKAGING, manufactured by Telectronics, Inc.. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K810410 · Telectronics, Inc. · Cardiovascular device
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Mar 1981
Decision
15d
Days
Class 3
Risk

K810410 is an FDA 510(k) clearance for the STERILE PACKAGING. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Telectronics, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 5, 1981 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3610 - 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: High-complexity regulatory submission. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Telectronics, Inc. devices

FDA 510(k) Submission Details - K810410

510(k) Number K810410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1981
Decision Date March 05, 1981
Days to Decision 15 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
110d faster than avg
Panel avg: 125d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

DXY Device Classification - Class 3, Premarket Approval

Product Code DXY Implantable Pacemaker Pulse-generator
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3610
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - DXY Implantable Pacemaker Pulse-generator

All 339
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K810410.
INTERMEDICS CYBERLITH I BIOPOLAR CARDI
K810383 · Intermedics, Inc. · Apr 1981
CYBERLITH I PULSE GENERATOR MODEL 253-04
K810385 · Intermedics, Inc. · Apr 1981
THINLITH II PULSE GNEERATOR MODEL 227-05
K810386 · Intermedics, Inc. · Mar 1981
MULTI-PROGRAMMABLE PACEMAKER & PROGRMR.
K801584 · Medtronic Vascular · Feb 1981
SIEMENS-ELEMA PULSE GENERATOR 678
K802864 · Siemens Elema AB · Feb 1981
SIEMENS-ELEMA MYOCARDIAL LEAD
K810036 · Siemens Elema AB · Jan 1981