Cleared Traditional

INTERMEDICS ADAPTAID STEP-DOWN ADAPTER (K812812) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K812812 · Intermedics, Inc. · Cardiovascular device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Oct 1981

Decision

21d

Days

Class 2

Risk

K812812 is an FDA 510(k) clearance for the INTERMEDICS ADAPTAID STEP-DOWN ADAPTER. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Intermedics, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 27, 1981 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3620 - 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 Intermedics, Inc. devices

Submission Details

510(k) Number	K812812 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 06, 1981
Decision Date	October 27, 1981
Days to Decision	21 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

104d faster than avg

Panel avg: 125d · This submission: 21d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	DTD Pacemaker Lead Adaptor
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 870.3620

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 - DTD Pacemaker Lead Adaptor

All 44

Devices cleared under the same product code (DTD) and FDA review panel - the closest regulatory comparables to K812812.

MODEL 366-07 ADAPT AID LEAD ADAPTER

K822704 · Intermedics, Inc. · Nov 1982

MODEL 5866-26 LEAD ADAPTER KIT

K820935 · Medtronic Vascular · Apr 1982

ADAPTAID #365-38

K812756 · Intermedics, Inc. · Oct 1981

ADAPTAID LEAD ADAPTER, #365-17

K811920 · Intermedics, Inc. · Aug 1981

ADAPTAID LEAD ADAPTER #365-25

K811938 · Intermedics, Inc. · Aug 1981

MODEL 5866-24 LEAD ADAPTOR KIT

K811349 · Medtronic Vascular · Jun 1981

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K812812

Intermedics, Inc.

Mchenry, IL · US

Regulatory profile

211 submissions 201 cleared

95% clearance rate · Active in Cardiovascular

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

Verify on FDA.gov

510k Database

510(k) clearances indexed 175,450

Regulatory data since 1976

FDA monthly sync Active