Intermedics, Inc.: FDA filings under this applicant name
FDA lists 211 510(k) clearances under the applicant name “Intermedics, Inc.” (first 1977, latest 1996), across 24 product codes in 9 review panels. Median 510(k) review time under this name: 55 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 |
|---|---|---|---|
| DTB | Permanent Pacemaker Electrode | 105 | 105 |
| DXY | Implantable Pacemaker Pulse-Generator | 52 | 52 |
| DTD | Pacemaker Lead Adaptor | 14 | 14 |
| FRN | Pump, Infusion | 7 | 7 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 5 | 5 |
| KRG | Programmer, Pacemaker | 4 | 4 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 3 | 3 |
| DTE | Pulse-Generator, Pacemaker, External | 2 | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 2 |
| BXN | Stimulator, Nerve, Battery-Powered | 1 | 1 |
Plus 14 more product codes.
Review panels
- Cardiovascular (188)
- General Hospital (7)
- General and Plastic Surgery (4)
- Neurology (3)
- Ophthalmic (2)
- Anesthesiology (1)
- Ear, Nose and Throat (1)
- Hematology (1)
- Physical Medicine (1)
Most recent Intermedics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K954610 | MODEL 430-07 ENDOCARDIAL PACING LEAD | DTB | 1996-12-16 | 439 |
| K955122 | INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD | DTB | 1996-11-04 | 361 |
| K962174 | BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07) | DTB | 1996-08-21 | 77 |
| K955550 | CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD | DTB | 1996-06-19 | 197 |
| K960281 | IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY | DTB | 1996-06-18 | 151 |
| K954719 | INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD | DTB | 1996-02-27 | 137 |
| K933278 | INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04 | KRG | 1995-03-15 | 624 |
| K922042 | CARDIFIX ENDOCARDIAL PACING LEAD | DTB | 1993-04-29 | 363 |
| K922972 | MODELS 438-05 AND 435-05 IMPLANTABLE PACING LEAD | DTB | 1993-01-22 | 217 |
| K920530 | INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG | DXY | 1992-03-17 | 41 |
201 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Intermedics, 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 Intermedics, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via DXY)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- C1820 — Generator, neurostimulator (implantable), with rechargeable battery and charging system (via DXY)
- 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.
- Intermedics Orthopedics (108 510(k)s)
- Intermedics Intraocular, Inc. (4 510(k)s)
- Intermedics/Infusaid, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Intermedics, Inc.?
FDA lists 211 510(k) clearances under the applicant name “Intermedics, Inc.” (first 1977, latest 1996), across 24 product codes in 9 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 Intermedics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Intermedics, Inc. is 55 days.
Which FDA product codes appear under Intermedics, Inc.?
The most frequent FDA product codes under this applicant name are DTB (Permanent Pacemaker Electrode, 105); DXY (Implantable Pacemaker Pulse-Generator, 52); DTD (Pacemaker Lead Adaptor, 14).
Next steps
- See all 211 Intermedics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DTB, Intermedics, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.