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

YearClearancesMedian review days
20120—
20130—
20140—
20150—
20161179
20170—
20180—
20190—
20200—
20210—
20220—
20230—
20240—
20250—
20260—

Top product codes

Product codeDeviceSubmissions510(k) clearances
HQEInstrument, Vitreous Aspiration And Cutting, Ac-Powered1414
HQCUnit, Phacofragmentation22
EQHSource, Carrier, Fiberoptic Light11
HKPInstrument, Vitreous Aspiration And Cutting, Battery-Powered11
HMXCannula, Ophthalmic11
HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)11
HSZInstrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment11
LXPPlug, Scleral11
MRHPump, Infusion, Ophthalmic11

Review panels

Most recent Medical Instrument Development Laboratories, Inc. 510(k) clearances

510(k)DeviceProduct codeDecision dateReview days
K153168Bi-Blade Vitrectomy CutterHQE2016-04-29179
K102222ULTIMATE VIT ENHAMCER (UVE)HQE2011-04-08245
K020911MID LABS AUTONOMOUS VIT ENHANCER (AVE)HQE2002-04-2940
K992943VIT ENHANCERHQE1999-12-10101
K971067DIGI-INJECTORMRH1997-09-19179
K950287UNIVIT PROBEHKP1995-04-1076
K934600MICRODRIVEHQE1994-07-27306
K932669SUPRA-VIT(TM)HQE1994-06-03366
K932131MID LABS TWIN ILLUMINATOREQH1994-04-01333
K924222MID LABS, INC. VIT MATEHQE1993-01-27159

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):

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.

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

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.

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