Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Manan Medical Products, Inc. · Predicate Candidate Screening
39 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
84 daysmedian FDA review time
239 days90th percentile
39clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K052802 | MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE | Manan Medical Products, Inc. | 2005-11-01 | 29 | 0 |
| K011209 | MANAN SPRITACRE SPINAL NEEDLES | Manan Medical Products, Inc. | 2001-06-26 | 68 | 0 |
| K983620 | MANAN SPINAL NEEDLES | Manan Medical Products, Inc. | 1999-01-08 | 85 | 0 |
| K980536 | EPIDURAL NEEDLE | Manan Medical Products, Inc. | 1998-07-31 | 170 | 0 |
| K981386 | MANAN BLUNT NEEDLE | Manan Medical Products, Inc. | 1998-06-29 | 74 | 0 |
| K980211 | MRI CHIBA,SPINAL,BREAST LOCALIZATION,AUTOMATIC CUTTING NEEDL | Manan Medical Products, Inc. | 1998-02-06 | 16 | 0 |
| K974446 | MANAN AUTOMATIC CUTTING NEEDLE | Manan Medical Products, Inc. | 1998-01-08 | 44 | 0 |
| K962977 | MRI COMPATIBLE BIOPSY NEEDLES | Manan Medical Products, Inc. | 1997-10-09 | 435 | 0 |
| K963767 | MANAN V.S. ACCESS NEEDLE/SET | Manan Medical Products, Inc. | 1997-05-16 | 239 | 0 |
| K961986 | MANAN D BAG | Manan Medical Products, Inc. | 1997-03-13 | 296 | 0 |
| K962001 | MANAN PEDIATRIC BONE MARROW ACCESS NEEDLE | Manan Medical Products, Inc. | 1997-01-10 | 233 | 0 |
| K963849 | MANAN D BAG | Manan Medical Products, Inc. | 1996-12-13 | 79 | 0 |
| K963743 | MANAN PROSTATE UNI-LOCK | Manan Medical Products, Inc. | 1996-12-06 | 80 | 0 |
| K961377 | MANAN PROSTATE LOCKING INTRODUCER SET | Manan Medical Products, Inc. | 1996-07-03 | 84 | 0 |
| K961216 | MANAN INTRODUCER SHEALTH/NEEDLE | Manan Medical Products, Inc. | 1996-05-23 | 56 | 0 |
| K953601 | MANAN UNIVERSAL SUMP DRAINAGE CATHETER | Manan Medical Products, Inc. | 1996-03-26 | 237 | 0 |
| K953713 | MANAN GENERAL UTILITY DRAINAGE CATHETER | Manan Medical Products, Inc. | 1996-03-26 | 251 | 0 |
| K954043 | MANAN BILIARY DRAINAGE CATHETER | Manan Medical Products, Inc. | 1996-03-26 | 210 | 0 |
| K954132 | MANAN MANTA CATHETER FIXATION DISK | Manan Medical Products, Inc. | 1996-03-26 | 207 | 0 |
| K954147 | MANAN MALECOT BASKET DRAINAGE CATHETER | Manan Medical Products, Inc. | 1996-03-26 | 203 | 0 |
| K953547 | MANAN NEPHROSTOMY DRAINAGE CATHETER | Manan Medical Products, Inc. | 1995-08-30 | 33 | 0 |
| K943649 | GERTIE MARX NEEDLE | Manan Medical Products, Inc. | 1995-03-22 | 237 | 0 |
| K950732 | MANAN SUPER-CORE BIOPSY NEEDLE | Manan Medical Products, Inc. | 1995-03-02 | 14 | 0 |
| K943653 | MAMMOCORE BIOPSY TRAY | Manan Medical Products, Inc. | 1995-01-30 | 186 | 0 |
| K943651 | TECHNA-CUT ASPIRATION NEEDLE | Manan Medical Products, Inc. | 1994-09-29 | 63 | 0 |
| K943650 | LIVER BIOPSY KIT | Manan Medical Products, Inc. | 1994-08-26 | 29 | 0 |
| K940024 | MANAN GENERAL PURPOSE INTRODUCER NEEDLE | Manan Medical Products, Inc. | 1994-02-25 | 53 | 0 |
| K940025 | MANAN BONE MARROW HARVEST NEEDLES | Manan Medical Products, Inc. | 1994-02-25 | 53 | 0 |
| K940365 | MANAN ADAPTER FOR BARD BIOPTY SYSTEM | Manan Medical Products, Inc. | 1994-02-25 | 30 | 0 |
| K933448 | MANAN ADAPTER FOR BIP BIOPSY DEVICE | Manan Medical Products, Inc. | 1993-11-12 | 121 | 0 |
| K914941 | SIMON BREAST LESION LOCALIZATION NEEDLE | Manan Medical Products, Inc. | 1992-05-14 | 192 | 0 |
| K914874 | MANAN PRO-MAG AUTOMATIC BIOPSY DEVICE | Manan Medical Products, Inc. | 1992-02-18 | 112 | 0 |
| K912074 | BONE MARROW BIOPSY TRAY | Manan Medical Products, Inc. | 1991-08-28 | 110 | 0 |
| K902177 | MANAN BONE BIOPSY NEEDLE | Manan Medical Products, Inc. | 1990-09-05 | 113 | 0 |
| K900978 | MANAN ARTERIAL CATHETER NEEDLE | Manan Medical Products, Inc. | 1990-08-23 | 174 | 0 |
| K902622 | MANAN PROSTATE SEEDING NEEDLE | Manan Medical Products, Inc. | 1990-08-10 | 57 | 1 |
| K895897 | MANAN PROSTATIC BIOPSY NEEDLE | Manan Medical Products, Inc. | 1989-10-18 | 12 | 0 |
| K890925 | MANAN BONE MARROW BIOPSY NEEDLE | Manan Medical Products, Inc. | 1989-04-11 | 46 | 0 |
| K883744 | MANAN HUBER STYLE INFUSION NEEDLE | Manan Medical Products, Inc. | 1988-09-28 | 27 | 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