Medical Instrument Development Laboratories, Inc.: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Medical Instrument Development Laboratories, Inc.” (first 1982, latest 2016), across 9 product codes in 3 review panels. Median 510(k) review time under this name: 98 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 | 1 | 179 |
| 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 |
|---|---|---|---|
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 14 | 14 |
| HQC | Unit, Phacofragmentation | 2 | 2 |
| EQH | Source, Carrier, Fiberoptic Light | 1 | 1 |
| HKP | Instrument, Vitreous Aspiration And Cutting, Battery-Powered | 1 | 1 |
| HMX | Cannula, Ophthalmic | 1 | 1 |
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | 1 | 1 |
| HSZ | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | 1 | 1 |
| LXP | Plug, Scleral | 1 | 1 |
| MRH | Pump, Infusion, Ophthalmic | 1 | 1 |
Review panels
- Ophthalmic (21)
- Ear, Nose and Throat (1)
- Orthopedic (1)
Most recent Medical Instrument Development Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K153168 | Bi-Blade Vitrectomy Cutter | HQE | 2016-04-29 | 179 |
| K102222 | ULTIMATE VIT ENHAMCER (UVE) | HQE | 2011-04-08 | 245 |
| K020911 | MID LABS AUTONOMOUS VIT ENHANCER (AVE) | HQE | 2002-04-29 | 40 |
| K992943 | VIT ENHANCER | HQE | 1999-12-10 | 101 |
| K971067 | DIGI-INJECTOR | MRH | 1997-09-19 | 179 |
| K950287 | UNIVIT PROBE | HKP | 1995-04-10 | 76 |
| K934600 | MICRODRIVE | HQE | 1994-07-27 | 306 |
| K932669 | SUPRA-VIT(TM) | HQE | 1994-06-03 | 366 |
| K932131 | MID LABS TWIN ILLUMINATOR | EQH | 1994-04-01 | 333 |
| K924222 | MID LABS, INC. VIT MATE | HQE | 1993-01-27 | 159 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medical Instrument Development 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 Medical Instrument Development Laboratories, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via MRH)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via MRH)
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 Components, Inc. (63 510(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)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medical Instrument Development Laboratories, Inc.?
FDA lists 23 510(k) clearances under the applicant name “Medical Instrument Development Laboratories, Inc.” (first 1982, latest 2016), across 9 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 Medical Instrument Development Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medical Instrument Development Laboratories, Inc. is 98 days.
Which FDA product codes appear under Medical Instrument Development Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered, 14); HQC (Unit, Phacofragmentation, 2); EQH (Source, Carrier, Fiberoptic Light, 1).
Next steps
- See all 23 Medical Instrument Development Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HQE, Medical Instrument Development 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.