510(k) Report

FDA applicant

Breg, Inc.

Vista, CA16 decisions1991–20191 recall

FDA records 16 decisions for Breg, Inc. (Vista, CA) from 1991 to 2019: 16 510(k) clearances. Most are in product codes ILO (Pack, Hot Or Cold, Water Circulating) and MEB (Pump, Infusion, Elastomeric). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 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, physical medicine panel, where it files most

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

FDA decisions per year

1in 2019

2007: 12019: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Breg, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Breg, 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?

  • ILOPack, Hot Or Cold, Water Circulating6decisions
  • MEBPump, Infusion, Elastomeric5decisions
  • FRNPump, Infusion2decisions
  • BXBExerciser, Powered1decision
  • LXVApparatus, Vestibular Analysis1decision
  • IRPMassager, Powered Inflatable Tube1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K183702Polar Care WaveBreg, Inc. · 20193cite it
  • K914434Polar PadsBreg, Inc. · 19911cites it
  • K013928Pain Care 3200Breg, Inc. · 20011cites it
  • K911795Kinesthetic Ability Trainer (K.a.T., Model 1000)Breg, Inc. · 19911cites it
  • K961855Polar Care (Model 500/50000)Breg, Inc. · 19961cites it
  • K983454Pain Care 2000Breg, Inc. · 19981cites it

What has FDA decided for it lately?

  • K183702Polar Care WaveBreg, Inc. · 2019
  • K070402Modification to Polar Care 500Breg, Inc. · 2007
  • K041714E-Pain CareBreg, Inc. · 2004
  • K020988Pain Care 4200Breg, Inc. · 2002
  • K013928Pain Care 3200Breg, Inc. · 2001
  • K003611Pain Care Multi-Port Catheter, Model 2000LBreg, Inc. · 2000
  • K002073Pain Care 3000Breg, Inc. · 2000
  • K002321Pain Care 2000LBreg, Inc. · 2000

All 16 as Breg, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K920581BREG Sterile Polar Pads; 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s…Jan 14, 2013Class II