Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Origin Medsystems, Inc. — Predicate Candidate Screening
50 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
103 daysmedian FDA review time
333 days90th percentile
50clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K992353 | BLUNT TIP TROCAR PORT | Origin Medsystems, Inc. | 1999-07-30 | 16 | 0 |
| K981700 | VASOVIEW DISSECTION/VESSEL HARVESTING SYSTEM | Origin Medsystems, Inc. | 1998-05-29 | 15 | 0 |
| K972685 | ORIGIN LIGATOR DEVICE | Origin Medsystems, Inc. | 1997-10-01 | 76 | 0 |
| K970611 | ORIGIN CARDIAC STABLIZER OCCLUDER | Origin Medsystems, Inc. | 1997-08-19 | 182 | 0 |
| K965121 | CANNULA | Origin Medsystems, Inc. | 1997-03-20 | 87 | 0 |
| K964171 | VASOVIEW BALLOON DISSECTION SYSTEM | Origin Medsystems, Inc. | 1997-02-14 | 119 | 0 |
| K962104 | AIRLIFT BALLOON RETRACTON SYSTEM | Origin Medsystems, Inc. | 1996-09-11 | 104 | 0 |
| K962005 | EXTRAHAND BALLOON RETRACTOR | Origin Medsystems, Inc. | 1996-08-12 | 82 | 0 |
| K960936 | RESPOSABLE TROCAR SYSTEM [5MM, 5MM SHORT, 10MM AND 12MM SIZE | Origin Medsystems, Inc. | 1996-07-24 | 138 | 0 |
| K960637 | 5MM ENDOSCOPE | Origin Medsystems, Inc. | 1996-06-14 | 121 | 0 |
| K955163 | DISSECTION PROBE | Origin Medsystems, Inc. | 1996-01-24 | 72 | 0 |
| K954174 | DUO BALLOON SYSTEM (DBS) 2 [10 AND 12 MM SIZES] | Origin Medsystems, Inc. | 1995-11-09 | 65 | 0 |
| K954175 | DUO BALLOON SYSTEM (DBS) 1[10 AND 12 MM SIZES] | Origin Medsystems, Inc. | 1995-11-09 | 65 | 0 |
| K953377 | DISTENTION BALLOON | Origin Medsystems, Inc. | 1995-10-23 | 96 | 0 |
| K953561 | PREPERITONEAL DISTENTION BALLOON SYSTEMS (MODIFICATION) | Origin Medsystems, Inc. | 1995-08-11 | 28 | 0 |
| K946002 | ORIGIN PREPERITONEAL DISSECTION BALLOON SYSTEM (PDBS)--EXTRA | Origin Medsystems, Inc. | 1995-01-05 | 44 | 0 |
| K944415 | ORIGIN TACKER SYSTEM | Origin Medsystems, Inc. | 1994-11-28 | 81 | 0 |
| K945023 | ORIGIN PIXIE STIC INTRODUCER SLEEVE | Origin Medsystems, Inc. | 1994-11-04 | 22 | 0 |
| K944304 | ORIGIN BALLOON ANCHOR | Origin Medsystems, Inc. | 1994-09-23 | 21 | 0 |
| K942678 | LIFTING DISTENTION BALLOON SYSTEM | Origin Medsystems, Inc. | 1994-07-08 | 31 | 0 |
| K942491 | ORIGIN BALLOON RETRACTOR | Origin Medsystems, Inc. | 1994-07-07 | 43 | 0 |
| K942636 | PSB PREPERITONEAL STRUCTURE BALLOON | Origin Medsystems, Inc. | 1994-07-01 | 28 | 0 |
| K940875 | ADJUSTABLE BALLOON DISSECTION CANNULA | Origin Medsystems, Inc. | 1994-05-03 | 67 | 0 |
| K930813 | PISTOL SUCTION/IRRIGATION PROBE | Origin Medsystems, Inc. | 1994-03-31 | 407 | 0 |
| K930848 | SENSING TIP SURGICAL TROCAR | Origin Medsystems, Inc. | 1994-03-01 | 376 | 0 |
| K931522 | FASCIAL CLOSURE DEVICE | Origin Medsystems, Inc. | 1994-02-03 | 314 | 0 |
| K933075 | LAPAROSCOPIC RETRACTOR | Origin Medsystems, Inc. | 1994-02-03 | 225 | 0 |
| K935426 | PREPERITONEAL DISTENTION BALLOON SYSTEM | Origin Medsystems, Inc. | 1994-01-26 | 77 | 0 |
| K933724 | SENSOR-TIP TROCAR | Origin Medsystems, Inc. | 1993-12-27 | 147 | 0 |
| K933106 | ENDOSCOPE | Origin Medsystems, Inc. | 1993-10-19 | 116 | 0 |
| K926480 | LAPAROSCOPIC BALLOON RETRACTOR | Origin Medsystems, Inc. | 1993-10-15 | 290 | 0 |
| K934134 | DISTENTION INSTRUMENT, MODIFICATION | Origin Medsystems, Inc. | 1993-10-05 | 48 | 0 |
| K921103 | RETRACTION INSTRUMENT | Origin Medsystems, Inc. | 1993-09-09 | 549 | 0 |
| K932229 | SURGICAL TROCAR AND TROCAR SLEEVE | Origin Medsystems, Inc. | 1993-08-18 | 103 | 0 |
| K924011 | ORIGIN BLUNT TIP SURGICAL TROCAR | Origin Medsystems, Inc. | 1993-07-09 | 333 | 7 |
| K930301 | TROCAR SHEATH ANCHOR | Origin Medsystems, Inc. | 1993-07-09 | 169 | 0 |
| K922094 | DISSECTION INSTRUMENT | Origin Medsystems, Inc. | 1993-03-18 | 317 | 0 |
| K921040 | ENDOSCOPE | Origin Medsystems, Inc. | 1992-12-24 | 295 | 0 |
| K922751 | ORIGIN FLEXIBLE PORT | Origin Medsystems, Inc. | 1992-11-20 | 165 | 0 |
| K922460 | ORIGIN SECONDARY CANNULA AND TROCAR | Origin Medsystems, Inc. | 1992-09-16 | 113 | 0 |
| K920599 | HOOK SURGICAL INSTRUMENT | Origin Medsystems, Inc. | 1992-07-15 | 155 | 0 |
| K915116 | TROCAR SHEATH ANCHOR | Origin Medsystems, Inc. | 1992-06-12 | 212 | 0 |
| K913816 | ORIGINEEDLE, MODIFICATION | Origin Medsystems, Inc. | 1991-11-08 | 74 | 0 |
| K914203 | LAPAROSCOPIC BALLOON RETRACTOR | Origin Medsystems, Inc. | 1991-10-09 | 20 | 0 |
| K904848 | PORT-OF-ORGIN(TM) SINGLE-USE TROCAR AND SLEEVE | Origin Medsystems, Inc. | 1991-04-08 | 164 | 0 |
| K904849 | ORIGINEEDLE(TM) | Origin Medsystems, Inc. | 1991-03-29 | 154 | 0 |
| K904156 | ORIGIN(TM) CEMENT EXTRACT SYST STD-PR/SPL-PR KITS | Origin Medsystems, Inc. | 1990-11-27 | 81 | 0 |
| K904180 | PROSTHETIC CEMENT REMOVER | Origin Medsystems, Inc. | 1990-11-20 | 70 | 0 |
| K890989 | DR. HERZBERG DISPOSABLE EXTERNAL FIXATOR | Origin Medsystems, Inc. | 1990-04-05 | 401 | 0 |
| K896584 | ARTHROSCOPIC TUBING SHEATH | Origin Medsystems, Inc. | 1989-12-27 | 36 | 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