Intramed Laboratories, Inc.: FDA clearances and approvals
Intramed Laboratories, Inc. has 14 FDA 510(k) clearances (first 1987, latest 1996), across 12 product codes in 7 review panels. Median 510(k) review time: 100 days.
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 |
|---|---|---|---|
| LYK | Angioscope | 2 | 2 |
| MGZ | Valvulotome | 2 | 2 |
| DQI | Withdrawal/Infusion Pump | 1 | 1 |
| FBN | Choledochoscope And Accessories, Flexible/Rigid | 1 | 1 |
| FFL | Dislodger, Stone, Basket, Ureteral, Metal | 1 | 1 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | 1 | 1 |
| FZP | Clip, Implantable | 1 | 1 |
| HET | Laparoscope, Gynecologic (And Accessories) | 1 | 1 |
| HIH | Hysteroscope (And Accessories) | 1 | 1 |
| HRH | Trephine, Manual, Ophthalmic | 1 | 1 |
Plus 2 more product codes.
Review panels
- Cardiovascular (5)
- Gastroenterology and Urology (3)
- Obstetrics and Gynecology (2)
- General Hospital (1)
- Ophthalmic (1)
- Orthopedic (1)
- General and Plastic Surgery (1)
Most recent Intramed Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K953258 | TITANIUM HEMOSTATIC CLIP | FZP | 1996-01-05 | 177 |
| K942457 | GRAFT THROMBECTOMY INSTRUMENTS | MCW | 1995-02-07 | 259 |
| K931792 | ARTHROSCOPE | HRH | 1994-06-13 | 427 |
| K925283 | VALVULOTOME | MGZ | 1994-02-10 | 478 |
| K934696 | ANGIOSCOPE | LYK | 1994-01-18 | 110 |
| K922114 | ENDOSCOPIC RETRIEVAL BASKET | FFL | 1992-08-03 | 90 |
| K914385 | OPTICAL VALVULOTOME | MGZ | 1992-03-02 | 153 |
| K904465 | FLEXIBLE ARTHROSCOPE | HRX | 1990-12-20 | 80 |
| K903528 | LAPAROSCOPE | HET | 1990-09-04 | 29 |
| K902444 | CLEARVIEW(TM) ANGIOSCOPIC IRRIGATION PUMP | DQI | 1990-08-30 | 90 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Intramed Laboratories, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Intramed Laboratories, Inc.'s product codes (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via DQI)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via DQI)
Frequently asked questions
How many FDA 510(k) clearances does Intramed Laboratories, Inc. have?
Intramed Laboratories, Inc. has 14 FDA 510(k) clearances (first 1987, latest 1996), across 12 product codes in 7 review panels.
How long does FDA take to clear Intramed Laboratories, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Intramed Laboratories, Inc.'s cleared 510(k)s is 100 days.
What devices does Intramed Laboratories, Inc. make?
Its most frequent FDA product codes are LYK (Angioscope, 2); MGZ (Valvulotome, 2); DQI (Withdrawal/Infusion Pump, 1).
Has Intramed Laboratories, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Intramed Laboratories, Inc. Related entities may recall under other names.
Next steps
- See all 14 Intramed Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LYK, Intramed Laboratories, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.