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FDA 510(k)

Solo Pace Fusion System (SOLOFUSE1)

K-Number: K252674 · 2026-01-09

ApplicantSolo Pace, Inc.
Decision Date2026-01-09
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Solo Pace Fusion System (SOLOFUSE1) is the device name listed in this FDA 510(k) record. The listed applicant is Solo Pace, Inc.. It received FDA 510(k) clearance on 2026-01-09 under 510(k) number K252674. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Solo Pace Fusion System (SOLOFUSE1)?

Solo Pace Fusion System (SOLOFUSE1) is a medical device that received FDA 510(k) clearance on 2026-01-09. The listed applicant is Solo Pace, Inc.. The 510(k) number is K252674.

When did Solo Pace Fusion System (SOLOFUSE1) receive FDA 510(k) clearance?

Solo Pace Fusion System (SOLOFUSE1) received FDA 510(k) clearance on 2026-01-09, under 510(k) number K252674.

Who is the listed applicant for Solo Pace Fusion System (SOLOFUSE1)?

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

What is the FDA product code for Solo Pace Fusion System (SOLOFUSE1)?

The FDA product code for Solo Pace Fusion System (SOLOFUSE1) is DQX.

Other records listing Solo Pace, 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.

K241781Solo Pace Control

Related Devices (Code: DQX)

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.

K253667Accoat Guide WireSp Medical A/SK261640Merit MAK Nitinol/Gold-Tungsten Guide WireMerit Medical Ireland , Ltd.K254137InQwire Amplatz Guide WireMerit Medical Ireland, Ltd.K260544FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40FMD Co., Ltd.K253746Enroute 0.014'' Transcarotid GuidewireLake Region MedicalK253262EmeryGlide™ (EG18008901)Nano4imaging GmbH

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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