Mcgaw, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Mcgaw, Inc.” (first 1991, latest 1997), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 138 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under B. Braun, based on public ownership records.
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 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 7 | 7 |
| FRN | Pump, Infusion | 3 | 3 |
| LHI | Set, I.V. Fluid Transfer | 3 | 3 |
Review panels
- General Hospital (13)
Most recent Mcgaw, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K972678 | MILLENNIUM CRT INFUSION PUMP AND MILLENNIUM CRT INFUSION PUMP ADMINISTRATION SETS | FRN | 1997-10-07 | 83 |
| K955595 | SAFELINE MULTIDOSE VIAL ADAPTER | LHI | 1996-03-06 | 89 |
| K955594 | SAFELINE I.V. BAG ACCESS DEVICE | LHI | 1996-03-06 | 89 |
| K941244 | SAFELINE SYSTEM TURN LOCK CANNULA | FPA | 1994-11-29 | 259 |
| K932165 | INTRAVASCULAR ADMINISTRATION SET | FPA | 1994-04-13 | 344 |
| K931377 | SAFELINE SYSTEM IV ADMINISTRATION SETS & COMPONENT | FPA | 1994-03-07 | 354 |
| K932856 | IRRIGATION ACCESS CAP | FPA | 1994-01-26 | 230 |
| K922637 | HORIZON PUMP Y-TYPE BLOOD SET | FPA | 1993-06-04 | 365 |
| K921860 | MODIFICATION TO IV SPIKE | FPA | 1992-07-30 | 141 |
| K913661 | MODIFIED VOLUMETRIC INFUSION PUMP | FRN | 1991-12-18 | 138 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Mcgaw, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Mcgaw, Inc. (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)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Mcgaw Respiratory Therapy (8 510(k)s)
- Mcgaw Laboratories (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Mcgaw, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Mcgaw, Inc.” (first 1991, latest 1997), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Mcgaw, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mcgaw, Inc. is 138 days.
Which FDA product codes appear under Mcgaw, Inc.?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 7); FRN (Pump, Infusion, 3); LHI (Set, I.V. Fluid Transfer, 3).
Next steps
- See all 13 Mcgaw, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FPA, Mcgaw, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.