Regulatory status and quality.

The Heidelberg pH Capsule System is a Class I medical device, 510(k)-exempt and preamendments, classified under 21 CFR 876.1400. This page sets out its regulatory status and the quality framework under which it is manufactured.

Regulatory snapshot

ClassClass I

Premarket510(k)-exempt

StatusPreamendments

Regulation21 CFR 876.1400

Product codeFFT

EstablishmentRegistered

DeviceListed

Registration of an establishment or listing of a device does not denote FDA approval, clearance, or endorsement.

CLASSIFICATION

A Class I, 510(k)-exempt device.

The Heidelberg pH Capsule System is a Class I medical device that is exempt from premarket notification, or 510(k). It is a preamendments device, meaning it was legally marketed in the United States before May 28, 1976. It is classified under 21 CFR 876.1400, product code FFT.

Title 21

Code of Federal Regulations

§876.1400

Product code

FFT

The classification regulation for the device

Heidelberg Medical's manufacturing establishment is registered with the U.S. Food and Drug Administration, and the device is listed.

WHAT THIS MEANS

Reading the classification correctly.

PREAMENDMENTS

Marketed before May 28, 1976.

The device predates the 1976 Medical Device Amendments and is regulated on that basis.

510(k)-EXEMPT

No premarket notification.

Class I devices of this type are exempt from the 510(k) premarket notification process.

REGISTERED & LISTED

Establishment and device.

Heidelberg Medical's manufacturing establishment is registered with FDA, and the device is listed under product code FFT.

NOT AN FDA APPROVAL

Registration is not endorsement.

Registration of an establishment or listing of a device does not denote FDA approval, clearance, or endorsement.

INTENDED USE

What the device is for.

The Heidelberg pH Capsule System is indicated for the assessment of gastric acidity and as an aid in the diagnosis of hypochlorhydria, achlorhydria, and hyperchlorhydria. It is for use by qualified healthcare professionals.

QUALITY SYSTEM

Manufacturing is conducted under applicable FDA quality system requirements (21 CFR 820 / QMSR).

QMSR

The Quality Management System Regulation, effective February 2, 2026, aligns U.S. requirements with ISO 13485.

DESIGN CONTROLS

Class I devices of this type are exempt from design control requirements.

PHYSICIAN USE

Federal Law (USA) restricts these devices to sale by or on the order of a physician.

HEIDELBERGMED

Stay informed

Occasional updates from the lab. Unsubscribe anytime.

Thanks — you're on the list.

Explore

Technology Evidence About Contact For Patients ↗

Science

The physiology Conditions Diagnostic patterns

Audiences

Physicians Researchers Pharma & CROs

The Heidelberg pH Capsule is a Class I, 510(k)-exempt, preamendments device, classified under 21 CFR §876.1400. Registration of an establishment or listing of a device does not denote FDA approval, clearance, or endorsement.