Cleared Traditional

K221141 - PageWriter TC35 Cardiograph

K221141 is an FDA 510(k) clearance for PageWriter TC35 Cardiograph, manufactured by Medizin Systeme Boblingen GmbH. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K221141 · Medizin Systeme Boblingen GmbH · Cardiovascular device
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Dec 2022
Decision
227d
Days
Class 2
Risk

K221141 is an FDA 510(k) clearance for the PageWriter TC35 Cardiograph. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Medizin Systeme Boblingen GmbH (Boblingen, DE). The FDA issued a Cleared decision on December 2, 2022 after a review of 227 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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: Standard predicate-based submission. Standard predicate reliance. 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 Medizin Systeme Boblingen GmbH devices

FDA 510(k) Submission Details - K221141

510(k) Number K221141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2022
Decision Date December 02, 2022
Days to Decision 227 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 125d · This submission: 227d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 282
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K221141.
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