Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Breg, Inc. — Predicate Candidate Screening
16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
60 daysmedian FDA review time
211 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K183702 | Polar Care Wave | Breg, Inc. | 2019-03-01 | 60 | 0 |
| K070402 | MODIFICATION TO POLAR CARE 500 | Breg, Inc. | 2007-03-29 | 45 | 0 |
| K041714 | E-PAIN CARE | Breg, Inc. | 2004-10-01 | 100 | 0 |
| K020988 | PAIN CARE 4200 | Breg, Inc. | 2002-04-04 | 8 | 0 |
| K013928 | PAIN CARE 3200 | Breg, Inc. | 2001-12-03 | 5 | 0 |
| K003611 | PAIN CARE MULTI-PORT CATHETER, MODEL 2000L | Breg, Inc. | 2000-12-13 | 21 | 0 |
| K002073 | PAIN CARE 3000 | Breg, Inc. | 2000-09-19 | 71 | 0 |
| K002321 | PAIN CARE 2000L | Breg, Inc. | 2000-08-14 | 14 | 0 |
| K983454 | PAIN CARE 2000 | Breg, Inc. | 1998-12-16 | 77 | 0 |
| K963596 | POLAR CARE 300 | Breg, Inc. | 1996-12-04 | 86 | 0 |
| K961855 | POLAR CARE (MODEL 500/50000) | Breg, Inc. | 1996-08-09 | 87 | 0 |
| K950755 | FLEXMATE K500 | Breg, Inc. | 1995-10-05 | 230 | 0 |
| K920581 | POLAR PAD (STERILE) | Breg, Inc. | 1992-03-20 | 39 | 1 |
| K911795 | KINESTHETIC ABILITY TRAINER (K.A.T., MODEL 1000) | Breg, Inc. | 1991-11-19 | 211 | 0 |
| K914434 | POLAR PADS | Breg, Inc. | 1991-10-24 | 20 | 0 |
| K913729 | POLAR PUMP, MODEL 500 | Breg, Inc. | 1991-10-18 | 59 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda