Abbott Mfg., Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Abbott Mfg., Inc.” (first 1990, latest 1998), across 12 product codes in 3 review panels. Median 510(k) review time under this name: 106 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 Abbott, 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 |
|---|---|---|---|
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 2 | 2 |
| FRN | Pump, Infusion | 2 | 2 |
| CGN | Acid, Folic, Radioimmunoassay | 1 | 1 |
| CJW | Bromcresol Purple Dye-Binding, Albumin | 1 | 1 |
| CJY | Azo Dye, Calcium | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| FPK | Tubing, Fluid Delivery | 1 | 1 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 | 1 |
| KHS | Enzymatic, Carbon-Dioxide | 1 | 1 |
Plus 2 more product codes.
Review panels
Most recent Abbott Mfg., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K981457 | ALBP | CJW | 1998-05-27 | 34 |
| K981232 | CA | CJY | 1998-05-18 | 45 |
| K981231 | CO2 | KHS | 1998-05-12 | 39 |
| K965230 | ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP | FRN | 1997-07-03 | 184 |
| K971293 | LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE | FPA | 1997-06-27 | 81 |
| K953656 | ABBOTT IMX PROLACTIN(MODIFICATION) | CFT | 1995-10-03 | 77 |
| K953657 | ABBOTT AXSYM PROLACTIN(MODIFICATION) | CFT | 1995-09-25 | 69 |
| K944669 | FLEXIFLO QUANTUM ENTERAL PUMP | FRN | 1995-07-24 | 314 |
| K943691 | IMX FOLATE | CGN | 1995-03-23 | 237 |
| K943733 | FLEXIFLO SIX ENTERAL NUTRITION PUMP | LZH | 1994-12-12 | 132 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Abbott Mfg., 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 Abbott Mfg., 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.
- Abbott Laboratories (889 510(k)s)
- ABBOTT MEDICAL (60 510(k)s)
- Abbott Vascular (50 510(k)s)
- Abbott Diabetes Care, Inc. (39 510(k)s)
- Abbott Diagnostics (28 510(k)s)
- Abbott Point of Care, Inc. (22 510(k)s)
- Abbott Molecular, Inc. (18 510(k)s)
- Abbott Medical Optics, Inc. (13 510(k)s)
- Abbott (13 510(k)s)
- Abbott Spine, Inc. (13 510(k)s)
- Abbott Ireland Diagnostics Division (8 510(k)s)
- Abbott Diagnostics Scarborough, Inc. (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Abbott Mfg., Inc.?
FDA lists 14 510(k) clearances under the applicant name “Abbott Mfg., Inc.” (first 1990, latest 1998), across 12 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 Abbott Mfg., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Abbott Mfg., Inc. is 106 days.
Which FDA product codes appear under Abbott Mfg., Inc.?
The most frequent FDA product codes under this applicant name are CFT (Radioimmunoassay, Prolactin (Lactogen), 2); FRN (Pump, Infusion, 2); CGN (Acid, Folic, Radioimmunoassay, 1).
Next steps
- See all 14 Abbott Mfg., Inc. clearances with predicates and recalls
- Run predicate analysis for product code CFT, Abbott Mfg., 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.