FDA applicant

Tactile Medical

Minneapolis, MN3 decisions2024–20260 recalls

FDA records 3 decisions for Tactile Medical (Minneapolis, MN) from 2024 to 2026: 3 510(k) clearances. Most are in product codes JOW (Sleeve, Limb, Compressible) and BYI (Percussor, Powered-Electric). Its devices cite 4 predicates, 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 Tactile Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2024high 2 (2026) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Tactile Medical by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Tactile Medical’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 “Tactile”

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

Tactile Systems Technology, Inc. 5 Tactile Systems Technology, Inc. (Dba Tactile Medical) 3 Tactile Technologies, Ltd. 2

Tactile Medical

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Tactile”