Cleared Traditional

K770285 - BALL TIP, MODEL #030-188

K770285 is an FDA 510(k) clearance for BALL TIP, manufactured by Med Telectronics , Ltd.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K770285 · Med Telectronics , Ltd. · Cardiovascular device
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Feb 1977
Decision
10d
Days
Class 3
Risk

K770285 is an FDA 510(k) clearance for the BALL TIP, MODEL #030-188. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Med Telectronics , Ltd. (Walker, US). The FDA issued a Cleared decision on February 24, 1977 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3680 - 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 Med Telectronics , Ltd. devices

FDA 510(k) Submission Details - K770285

510(k) Number K770285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1977
Decision Date February 24, 1977
Days to Decision 10 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 125d · This submission: 10d
Pathway characteristics
Predicate-based equivalence.

DTB Device Classification - Class 3, Premarket Approval

Product Code DTB Permanent Pacemaker Electrode
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3680
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 - DTB Permanent Pacemaker Electrode

All 424
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K770285.
UNIPOLAR LEAD CONFIGURATION CONDUCTOR
K770468 · Daig Corp. · Apr 1977
TEMP. PERVENOUS LEAD W/REMOTE ANODE
K770214 · Cordis Corp. · Mar 1977
LEAD, HEART, BUTTERFLY CLAMP
K770416 · Arco Medical Products Co. · Mar 1977
PERM. IMPLANT. ENDOCARDIAL PAC. LEAD
K770195 · Daig Corp. · Feb 1977
CARDIAC ELECTRODE
K760443 · Meadox Medicals, Div. Boston Scientific Corp. · Aug 1976