510(k) Report

FDA applicant

12th Man Technologies, Inc.

Garden Grove, CA2 decisions2015–20150 recalls

FDA records 2 decisions for 12th Man Technologies, Inc. (Garden Grove, CA) in 2015: 2 510(k) clearances. Most are in product codes CBP (Valve, Non-Rebreathing) and MQC (Mouthguard, Prescription). 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, anesthesiology panel, where it files most

How often FDA has decided 12th Man Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2015

2015: 2
2015high 2 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — 12th Man Technologies, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like 12th Man Technologies, 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

Which product codes does it file in?

  • CBPValve, Non-Rebreathing1decision
  • MQCMouthguard, Prescription1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K151933BRX PRO Bruxism Guard12th Man Technologies, Inc. · 2015
  • K142402BigEasy Non-Rebreathing Valve12th Man Technologies, Inc. · 2015

All 2 as 12th Man Technologies, Inc. →