Kendall Mcgaw Laboratories, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Kendall Mcgaw Laboratories, Inc.” (first 1986, latest 1991), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 73 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| FRN | Pump, Infusion | 5 | 5 |
| FPA | Set, Administration, Intravascular | 3 | 3 |
| LHI | Set, I.V. Fluid Transfer | 2 | 2 |
| FPB | Filter, Infusion Line | 1 | 1 |
| FPD | Tube, Feeding | 1 | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 | 1 |
Review panels
Most recent Kendall Mcgaw Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K905611 | MICRORATE PLUS INTELLIGENT PUMP | FRN | 1991-03-01 | 80 |
| K905610 | MICRORATE INTELLIGENT PUMP | FRN | 1991-03-01 | 80 |
| K904855 | ADD-A-VIAL | LHI | 1990-11-19 | 21 |
| K904518 | VOLUMETRIC INFUSION PUMP | FRN | 1990-10-17 | 14 |
| K903809 | PROTECTED NEEDLE WITH OR WITHOUT IV SET | FPA | 1990-10-03 | 44 |
| K901065 | INFUSION PUMP | FRN | 1990-08-21 | 167 |
| K900865 | ADD-A-VIAL II BINARY CONNECTOR | LHI | 1990-07-11 | 138 |
| K896292 | 1.2 MICRON FILTER WITH IV SET | FPB | 1989-12-08 | 38 |
| K895109 | SECONDARY IV SET WITH PROTECTED NEEDLE | FPA | 1989-09-27 | 43 |
| K882159 | 522 INTELLIGENT PUMP | FRN | 1988-08-24 | 93 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Kendall Mcgaw Laboratories, 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 Kendall Mcgaw Laboratories, 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.
- Kendall Healthcare Products Co. Div.Of Tyco Health (66 510(k)s)
- Kendall Research Center (14 510(k)s)
- Kendall (12 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Kendall Mcgaw Laboratories, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Kendall Mcgaw Laboratories, Inc.” (first 1986, latest 1991), across 6 product codes in 2 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 Kendall Mcgaw Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kendall Mcgaw Laboratories, Inc. is 73 days.
Which FDA product codes appear under Kendall Mcgaw Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are FRN (Pump, Infusion, 5); FPA (Set, Administration, Intravascular, 3); LHI (Set, I.V. Fluid Transfer, 2).
Next steps
- See all 13 Kendall Mcgaw Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FRN, Kendall Mcgaw Laboratories, 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.