American Mcgaw: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “American Mcgaw” (first 1981, latest 1985), across 9 product codes in 3 review panels. Median 510(k) review time under this name: 50 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 | 3 | 3 |
| FKX | System, Peritoneal, Automatic Delivery | 2 | 2 |
| KPE | Container, I.V. | 2 | 2 |
| FDA | Enteroscope And Accessories | 1 | 1 |
| FLN | Monitor, Electric For Gravity Flow Infusion Systems | 1 | 1 |
| FRN | Pump, Infusion | 1 | 1 |
| KDJ | Set, Administration, For Peritoneal Dialysis, Disposable | 1 | 1 |
| KFX | Assembly, Thigh/Knee/Shank/Ankle/Foot, External | 1 | 1 |
| LHI | Set, I.V. Fluid Transfer | 1 | 1 |
Review panels
Most recent American Mcgaw 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K853549 | MCGAW/DROP WATCH FLOW MONITOR | FLN | 1985-11-12 | 78 |
| K843639 | ADD-A-VIAL SOLUTION TRANSFER DEVICE | LHI | 1985-01-14 | 119 |
| K843954 | MIXING CONTAINER | KPE | 1984-11-28 | 50 |
| K841729 | ACCUPRO ENTERAL FEEDING PUMP | FRN | 1984-06-01 | 37 |
| K840388 | PAB IV CONTAINER | KPE | 1984-03-06 | 36 |
| K840212 | CONCENTRATED PLATELET ADMIN. SET | FPA | 1984-03-06 | 47 |
| K831716 | CAPD - CATHETER ADAPTER | FKX | 1983-06-24 | 28 |
| K822240 | ETHYLENE OXIDE STERILIZ. PARAMETRIC REL. | KFX | 1982-12-30 | 156 |
| K820133 | MCGAW FAT EMULSION SET | FPA | 1982-04-06 | 78 |
| K813092 | ACCUPRO I.V. ADMINISTRATION SET | FPA | 1981-12-31 | 59 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named American Mcgaw.
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 American Mcgaw (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.
- American Dade (149 510(k)s)
- American Edwards Laboratories (89 510(k)s)
- American Medical Systems, Inc. (82 510(k)s)
- American Bioproducts Co. (79 510(k)s)
- American Monitor Corp. (73 510(k)s)
- American Pharmaseal Div. Ahsc (64 510(k)s)
- American Bentley (59 510(k)s)
- American Hospital Supply Corp. (56 510(k)s)
- American Research Products Co. (56 510(k)s)
- American Orthodontics (46 510(k)s)
- American Diagnostic Corp. (39 510(k)s)
- American Laboratory Supply, Inc. (36 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under American Mcgaw?
FDA lists 13 510(k) clearances under the applicant name “American Mcgaw” (first 1981, latest 1985), across 9 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by American Mcgaw?
The median time from FDA receipt to decision across 510(k)s cleared under the name American Mcgaw is 50 days.
Which FDA product codes appear under American Mcgaw?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 3); FKX (System, Peritoneal, Automatic Delivery, 2); KPE (Container, I.V., 2).
Next steps
- See all 13 American Mcgaw clearances with predicates and recalls
- Run predicate analysis for product code FPA, American Mcgaw'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.