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FDA 510(k)

Second Opinion® BLE

K-Number: K243230 · 2025-05-09

ApplicantPearl, Inc.
Decision Date2025-05-09
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Second Opinion® BLE is the device name listed in this FDA 510(k) record. The listed applicant is Pearl, Inc.. It received FDA 510(k) clearance on 2025-05-09 under 510(k) number K243230. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Second Opinion® BLE?

Second Opinion® BLE is a medical device that received FDA 510(k) clearance on 2025-05-09. The listed applicant is Pearl, Inc.. The 510(k) number is K243230.

When did Second Opinion® BLE receive FDA 510(k) clearance?

Second Opinion® BLE received FDA 510(k) clearance on 2025-05-09, under 510(k) number K243230.

Who is the listed applicant for Second Opinion® BLE?

The FDA 510(k) record lists Pearl, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Second Opinion® BLE?

The FDA product code for Second Opinion® BLE is QIH.

Other records listing Pearl, Inc. as applicant

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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Related Devices (Code: QIH)

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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