FDA applicant

Solo Pace, Inc.

San Francisco, CA2 decisions2025–20260 recalls

FDA records 2 decisions for Solo Pace, Inc. (San Francisco, CA) from 2025 to 2026: 2 510(k) clearances. Most are in product codes DQX (Wire, Guide, Catheter) and DTE (Pulse-Generator, Pacemaker, External). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Solo Pace, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2025high 1 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

FIG. 1 — Solo Pace, Inc. by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Solo Pace, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Solo”

FDA records each applicant name separately; these may or may not be the same firm.

Solo Pak Laboratories 4 Solo-Dex, Inc. 1 Solo-Sled, LLC 1

Solo Pace, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Solo”