Medical Components, Inc.: FDA filings under this applicant name
FDA lists 63 510(k) clearances under the applicant name “Medical Components, Inc.” (first 1980, latest 2025), across 29 product codes in 5 review panels. Median 510(k) review time under this name: 103 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 | 8 | 98 |
| 2013 | 5 | 154 |
| 2014 | 2 | 110 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 145 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Medical Components, Inc. took a median 145 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 120 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 9 | 9 |
| MSD | Catheter, Hemodialysis, Implanted | 8 | 8 |
| MPB | Catheter, Hemodialysis, Non-Implanted | 6 | 6 |
| LFJ | Catheter, Subclavian | 5 | 5 |
| DQO | Catheter, Intravascular, Diagnostic | 3 | 3 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 3 | 3 |
| DQY | Catheter, Percutaneous | 2 | 2 |
| DYB | Introducer, Catheter | 2 | 2 |
| FJS | Catheter, Peritoneal, Long-Term Indwelling | 2 | 2 |
| KNZ | Accessories, A-V Shunt | 2 | 2 |
Plus 19 more product codes.
Review panels
- Gastroenterology and Urology (31)
- General Hospital (16)
- Cardiovascular (9)
- Anesthesiology (4)
- General and Plastic Surgery (3)
Most recent Medical Components, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250836 | 14F Duo-Flow® Side X Side Double Lumen Catheter | MPB | 2025-08-12 | 145 |
| K141633 | PRO-PICC WITH VALVE TECHNOLOGY | LJS | 2014-09-29 | 103 |
| K132880 | MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLE | FPA | 2014-01-08 | 117 |
| K131687 | 6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET | LJS | 2013-08-16 | 67 |
| K130687 | 2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER | DYB | 2013-08-15 | 155 |
| K130923 | 5F DIGNITY CT TITANIUM PORT | LJT | 2013-07-31 | 119 |
| K124046 | VALVED TEARAWAY INTRODUCER GENERATION II | DYB | 2013-06-03 | 154 |
| K123617 | 3F PRO-PICC | LJS | 2013-05-15 | 173 |
| K122423 | VASU-PICC | LJS | 2012-12-12 | 125 |
| K121848 | SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM | MSD | 2012-09-21 | 88 |
53 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medical Components, 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 Medical Components, Inc. (a text match, not an official crosswalk):
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via JCY)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via JCY)
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.
- Medical Analysis Systems, Inc. (107 510(k)s)
- Medical Advances, Inc. (57 510(k)s)
- Medical Diagnostic Technologies, Inc. (57 510(k)s)
- Medical Devices, Inc. (49 510(k)s)
- Medical Device Technologies, Inc. (46 510(k)s)
- Medical Specialties, Inc. (40 510(k)s)
- Medical Device Inspection Co., Inc. (30 510(k)s)
- Medical Engineering Corp. (28 510(k)s)
- Medical Data Electronics (27 510(k)s)
- Medical Graphics Corp. (25 510(k)s)
- Medical Innovations Corp. (24 510(k)s)
- Medical Instrument Development Laboratories, Inc. (23 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medical Components, Inc.?
FDA lists 63 510(k) clearances under the applicant name “Medical Components, Inc.” (first 1980, latest 2025), across 29 product codes in 5 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 Medical Components, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medical Components, Inc. is 103 days.
Which FDA product codes appear under Medical Components, Inc.?
The most frequent FDA product codes under this applicant name are LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, 9); MSD (Catheter, Hemodialysis, Implanted, 8); MPB (Catheter, Hemodialysis, Non-Implanted, 6).
Next steps
- See all 63 Medical Components, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LJS, Medical Components, 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.