Breg, Inc.: FDA clearances and approvals
Breg, Inc. has 16 FDA 510(k) clearances (first 1991, latest 2019), across 6 product codes in 3 review panels. Median 510(k) review time: 60 days. openFDA lists 13 product recalls by a recalling firm named Breg, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 60 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Breg, Inc.'s cleared 510(k)s took a median 60 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 146 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ILO | Pack, Hot Or Cold, Water Circulating | 6 | 6 |
| MEB | Pump, Infusion, Elastomeric | 5 | 5 |
| FRN | Pump, Infusion | 2 | 2 |
| BXB | Exerciser, Powered | 1 | 1 |
| IRP | Massager, Powered Inflatable Tube | 1 | 1 |
| LXV | Apparatus, Vestibular Analysis | 1 | 1 |
Review panels
Most recent Breg, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K183702 | Polar Care Wave | IRP | 2019-03-01 | 60 |
| K070402 | MODIFICATION TO POLAR CARE 500 | ILO | 2007-03-29 | 45 |
| K041714 | E-PAIN CARE | FRN | 2004-10-01 | 100 |
| K020988 | PAIN CARE 4200 | MEB | 2002-04-04 | 8 |
| K013928 | PAIN CARE 3200 | MEB | 2001-12-03 | 5 |
| K003611 | PAIN CARE MULTI-PORT CATHETER, MODEL 2000L | FRN | 2000-12-13 | 21 |
| K002073 | PAIN CARE 3000 | MEB | 2000-09-19 | 71 |
| K002321 | PAIN CARE 2000L | MEB | 2000-08-14 | 14 |
| K983454 | PAIN CARE 2000 | MEB | 1998-12-16 | 77 |
| K963596 | POLAR CARE 300 | ILO | 1996-12-04 | 86 |
6 earlier clearances. See the full list in Caduvo.
Recalls
13 product recalls in 4 recall events; 1 initiated in the last five years. Most recent: 2023-09-13.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Breg, Inc.'s product codes (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Frequently asked questions
How many FDA 510(k) clearances does Breg, Inc. have?
Breg, Inc. has 16 FDA 510(k) clearances (first 1991, latest 2019), across 6 product codes in 3 review panels.
How long does FDA take to clear Breg, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Breg, Inc.'s cleared 510(k)s is 60 days.
What devices does Breg, Inc. make?
Its most frequent FDA product codes are ILO (Pack, Hot Or Cold, Water Circulating, 6); MEB (Pump, Infusion, Elastomeric, 5); FRN (Pump, Infusion, 2).
Has Breg, Inc. had device recalls?
openFDA lists 13 product recalls in 4 recall events by a recalling firm whose name matches Breg, Inc; the most recent began 2023-09-13. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 16 Breg, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ILO, Breg, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.