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FDA 510(k)

1NEED Pro

K-Number: K243472 · 2025-03-19

ApplicantCampomats S.R.L.
Decision Date2025-03-19
Product CodeQAI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

1NEED Pro is the device name listed in this FDA 510(k) record. The listed applicant is Campomats S.R.L.. It received FDA 510(k) clearance on 2025-03-19 under 510(k) number K243472. The device is classified under product code QAI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 1NEED Pro?

1NEED Pro is a medical device that received FDA 510(k) clearance on 2025-03-19. The listed applicant is Campomats S.R.L.. The 510(k) number is K243472.

When did 1NEED Pro receive FDA 510(k) clearance?

1NEED Pro received FDA 510(k) clearance on 2025-03-19, under 510(k) number K243472.

Who is the listed applicant for 1NEED Pro?

The FDA 510(k) record lists Campomats S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 1NEED Pro?

The FDA product code for 1NEED Pro is QAI.

Related Devices (Code: QAI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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