Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Device Technologies, Inc. — Predicate Candidate Screening
46 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
50 daysmedian FDA review time
128 days90th percentile
46clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K101832 | BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT | Medical Device Technologies, Inc. | 2010-08-27 | 57 | 0 |
| K053518 | INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM | Medical Device Technologies, Inc. | 2006-01-26 | 38 | 0 |
| K051421 | INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM | Medical Device Technologies, Inc. | 2005-08-30 | 90 | 0 |
| K050873 | CANALIZER HYDROPHILIC GUIDE WIRE | Medical Device Technologies, Inc. | 2005-05-26 | 50 | 0 |
| K043523 | INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLE | Medical Device Technologies, Inc. | 2005-02-11 | 53 | 0 |
| K042464 | V-CORE FULL CORE BREAST BIOPSY INSTRUMENT | Medical Device Technologies, Inc. | 2004-09-30 | 17 | 0 |
| K040427 | FIBREX CATHETER PATENCY DEVICE | Medical Device Technologies, Inc. | 2004-05-03 | 74 | 0 |
| K031442 | PBN GUIDEWIRES | Medical Device Technologies, Inc. | 2003-08-13 | 99 | 0 |
| K021606 | EN-SNARE ENDOVASCULAR SNARE AND CATHETER | Medical Device Technologies, Inc. | 2002-05-31 | 15 | 0 |
| K011790 | MICROCRUISER PLUS INTRODUCER SET | Medical Device Technologies, Inc. | 2001-09-05 | 89 | 0 |
| K000620 | PBN FALLOPIAN TUBE CATHETER SYSTEM | Medical Device Technologies, Inc. | 2000-10-30 | 249 | 0 |
| K002416 | GOLDEN-RULE SCALING CATHETER | Medical Device Technologies, Inc. | 2000-09-11 | 34 | 0 |
| K000433 | PBN HYSTERO-SALPINGOGRAPHY CATHETER SET | Medical Device Technologies, Inc. | 2000-06-16 | 128 | 0 |
| K990808 | PBN DILATORS | Medical Device Technologies, Inc. | 1999-11-26 | 260 | 0 |
| K990839 | TRU-CORE I REUSABLE BIOPSY INSTRUMENT | Medical Device Technologies, Inc. | 1999-05-20 | 66 | 0 |
| K991097 | PBN DRAINAGE CATHETER GUIDEWIRES | Medical Device Technologies, Inc. | 1999-04-23 | 22 | 0 |
| K982960 | MEICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSABLE AUTOMAT | Medical Device Technologies, Inc. | 1998-09-23 | 30 | 2 |
| K982085 | MEDICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSALE SEMI-AU | Medical Device Technologies, Inc. | 1998-07-17 | 32 | 0 |
| K980193 | MANAN GENERAL UTILITY DRAINAGE CATHETER | Medical Device Technologies, Inc. | 1998-05-27 | 127 | 0 |
| K980192 | MANAN NEPHROSTOMY DRAINAGE CATHETER | Medical Device Technologies, Inc. | 1998-05-27 | 127 | 0 |
| K980372 | MANAN VS ACCESS NEEDLE/SET | Medical Device Technologies, Inc. | 1998-04-27 | 87 | 0 |
| K980227 | MANAN GALACTOGRAPHY KIT | Medical Device Technologies, Inc. | 1998-04-23 | 91 | 0 |
| K981229 | MANAN MANTA CATHETER FIXATION DISK | Medical Device Technologies, Inc. | 1998-04-22 | 19 | 0 |
| K981258 | MANAN MALECOT BASKET DRAINAGE CATHETER | Medical Device Technologies, Inc. | 1998-04-22 | 16 | 0 |
| K974743 | MANAN | Medical Device Technologies, Inc. | 1998-04-06 | 108 | 0 |
| K974742 | MANAN POTTS-COURNAND NEEDLE | Medical Device Technologies, Inc. | 1998-04-06 | 108 | 0 |
| K974745 | MANAN GWI GUIDE WIRE INTRODUCER | Medical Device Technologies, Inc. | 1998-04-06 | 108 | 1 |
| K980452 | MANAN LIVER BIOPSY KIT | Medical Device Technologies, Inc. | 1998-02-18 | 13 | 0 |
| K980226 | MANAN PRO-MAG AUTOMATIC BIOPSY SYSTEM | Medical Device Technologies, Inc. | 1998-02-18 | 27 | 1 |
| K980191 | MANAN BILIARY DRAINAGE CATHETER | Medical Device Technologies, Inc. | 1998-02-09 | 20 | 0 |
| K980196 | MD TECH BIOPSY SET FOR BONE AND BONE MARROW | Medical Device Technologies, Inc. | 1998-02-03 | 14 | 12 |
| K980122 | MANAN SOFT TISSUE BIOPSY NEEDLES | Medical Device Technologies, Inc. | 1998-01-30 | 16 | 0 |
| K980005 | MANAN D BAG | Medical Device Technologies, Inc. | 1998-01-30 | 28 | 0 |
| K974815 | MANAN(TM) INTRODUCER SHEATH/NEEDLE | Medical Device Technologies, Inc. | 1998-01-09 | 17 | 0 |
| K980004 | MANAN GENERAL PURPOSE INTRODUCER NEEDLE | Medical Device Technologies, Inc. | 1998-01-09 | 7 | 0 |
| K974814 | MANAN(TM) SUPER-CORE BIOPSY NEEDLES | Medical Device Technologies, Inc. | 1998-01-09 | 17 | 0 |
| K974741 | MANAN ACCURA NEEDLE | Medical Device Technologies, Inc. | 1998-01-08 | 20 | 1 |
| K974766 | MANAN TECHNA-CUT ASPIRATION NEEDLE | Medical Device Technologies, Inc. | 1998-01-08 | 17 | 0 |
| K965037 | CELL RECOVERY SYSTEM | Medical Device Technologies, Inc. | 1997-01-08 | 22 | 0 |
| K962969 | MEDICAL DEVICE TECHNOLOGIES, INC.ULTRA | Medical Device Technologies, Inc. | 1996-12-06 | 128 | 0 |
| K961959 | MD TECH BIOPSY SET FOR BONE AND BONE MARROW | Medical Device Technologies, Inc. | 1996-07-19 | 60 | 0 |
| K960004 | CELL RECOVERY SYSTEM | Medical Device Technologies, Inc. | 1996-03-20 | 78 | 0 |
| K944522 | MORGANSTERN PROSTATE STABILIZATION AND SEEDING KIT | Medical Device Technologies, Inc. | 1995-02-24 | 161 | 1 |
| K944837 | MEDICAL DEVICE TECHNOLOGIES MANUAL BIOPSY NEEDLE | Medical Device Technologies, Inc. | 1994-10-14 | 14 | 0 |
| K921418 | ULTRA-CORE BIOPSY NEEDLES | Medical Device Technologies, Inc. | 1992-06-19 | 87 | 0 |
| K915417 | KOPAN'S TARGET | Medical Device Technologies, Inc. | 1992-01-14 | 43 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda