Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
BSY — Predicate Candidate Screening
116 FDA 510(k) clearances under this product code; the 50 most recent screened below.
62 daysmedian FDA review time
160 days90th percentile
116clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K031997 | MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTE | Mallinckrodt Dar S.R.L. | 2003-11-25 | 151 | 0 |
| K992902 | AMBU HAND POWER SUCTION PUMP | Ambu, Inc. | 1999-10-25 | 56 | 0 |
| K982945 | DUAL PURPOSE CLOSED CATHETER | Spirit Medical Systems, Inc. | 1998-09-22 | 32 | 0 |
| K981910 | SUCTION CATHETER | Ni-Med, Inc. | 1998-08-24 | 84 | 0 |
| K972258 | HI-CARE CLOSED SUCTION SYSTEM | Mallinckrodt Medical | 1997-12-29 | 195 | 0 |
| K973199 | AMSINO SUCTION CATHETER | Amsino Intl., Inc. | 1997-09-10 | 15 | 0 |
| K961707 | TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM | Sorenson Critical Care | 1997-03-11 | 313 | 1 |
| K964369 | TRACH CARE SET WITH MICROBAN | Ballard Medical Products | 1997-02-11 | 102 | 0 |
| K960488 | NEO 2 LINE SUCTION SYSTEM | Alcove Medical, Inc. | 1996-04-26 | 85 | 0 |
| K955831 | ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM | Sherwood Medical Co. | 1996-03-28 | 93 | 0 |
| K955645 | CATH-GUIDE | Hudson Respiratory Care, Inc. | 1996-03-12 | 91 | 0 |
| K952396 | REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTIO | Contour Fabricators of Florida, Inc. | 1995-08-15 | 85 | 0 |
| K952395 | REDI NURSE SYSTEM (RNS) STERILE WATER FOR IRRIGATION | Contour Fabricators of Florida, Inc. | 1995-08-15 | 85 | 0 |
| K953226 | PULM O2 SUCTION CATHETER TRAYS | Premium Plastics, Inc. | 1995-08-08 | 33 | 0 |
| K951506 | SUCTION CATHETER KIT, STERILE, SINGLE-USE | Trinity Laboratories, Inc. | 1995-07-03 | 91 | 0 |
| K945994 | DUAL PURPOSE CATHETER | Universal Medical Products, Inc. | 1995-06-21 | 211 | 0 |
| K951745 | CONNECTING TUBE | Vital Signs, Inc. | 1995-05-30 | 50 | 0 |
| K945950 | TRIGUARD(TM) SUCTION SYSTEM | Vital Signs, Inc. | 1994-12-27 | 21 | 0 |
| K944251 | KENDALL MODU-VAC CLOSED SUCTION SYSTEM | Kendall Healthcare Products Co. Div.Of Tyco Health | 1994-09-21 | 21 | 0 |
| K935600 | TRACHEAL SUCTION CATHETER | Puritas Health Care, Inc. | 1994-05-10 | 172 | 0 |
| K935583 | SUCTION SET, TRACHAEL | Puritas Health Care, Inc. | 1994-04-11 | 144 | 0 |
| K935553 | MULLY SUCTION STRAIGHT WITH FINGERTIP/WITH FUNNEL/WITH VACUT | Puritas Health Care, Inc. | 1994-01-14 | 58 | 0 |
| K934723 | ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM | Sherwood Medical Co. | 1993-11-30 | 61 | 0 |
| K925556 | ARGYLE ASPIR-FLEX SUCTION CATHETER | Sherwood Medical Co. | 1993-07-30 | 269 | 0 |
| K921851 | 4 SURE TM SUCTION CATHETERS & KITS | Boston Pacific Medical, Inc. | 1993-07-07 | 446 | 0 |
| K922843 | DYNAREX SUCTION CATHETERS & KITS | Dynarex Corp. | 1993-01-11 | 213 | 0 |
| K922148 | ARGYLE AERO-JET SUCTION CATHETER | Sherwood Medical Co. | 1992-12-07 | 214 | 0 |
| K923098 | STERILE MUCOUS SPECIMEN TRAP, DISPOSABLE | Trinity Laboratories, Inc. | 1992-09-21 | 88 | 0 |
| K903480 | HANN-VAC TM, DISPOSABLE,SUCTION CATHETER | Un-I-Med, Inc. | 1991-10-01 | 425 | 0 |
| K912596 | MECONIUM ASPIRATION | Pacific Device, Inc. | 1991-07-30 | 50 | 0 |
| K910239 | NEBU-SOL METERED DOSE DISPENSER (TM) | Dey Laboratories, Inc. | 1991-05-22 | 120 | 0 |
| K910909 | MUCAID | Vygon Corp. | 1991-05-20 | 76 | 0 |
| K910908 | MUCAID WITH SUCTION CATHETER AND EXTENSION TUBING | Vygon Corp. | 1991-05-20 | 76 | 0 |
| K903552 | ORAL-CATH SUCTION CATHETER | Concord Protex | 1991-01-02 | 149 | 0 |
| K903740 | TRACH-EZE | Sorex Medical | 1990-12-06 | 112 | 0 |
| K902093 | RESU-GARD CATHETER SUCTION | Amg Medical Equipments, Inc. | 1990-10-23 | 167 | 0 |
| K903669 | GENESIS INSUFFLATING CATHETER | General Medical Co. | 1990-09-12 | 30 | 0 |
| K902687 | STERI-CATH-DL | Concord/Portex | 1990-08-29 | 71 | 0 |
| K902814 | SUCTION CATHETER, STERILE | Orion Life Systems, Inc. | 1990-08-17 | 50 | 0 |
| K902297 | BUSSE BAC/SHIELD | Busse Hospital Disposables, Inc. | 1990-08-17 | 86 | 0 |
| K902383 | STERI-CATH(TM) | Concord/Portex | 1990-07-12 | 43 | 0 |
| K896887 | TRACHAEL SUCTION SET | Orion Life Systems, Inc. | 1990-04-23 | 136 | 0 |
| K896730 | SUCTION CATHETER STRAIGHT/COUDE | Unoplast A/S | 1990-03-30 | 120 | 0 |
| K896797 | SUCTION CATHETER KIT | Westmark, Sterile Packing Systems, Inc. (Sps) | 1990-02-16 | 77 | 0 |
| K896560 | MUCOUS TRAP | Westmark, Sterile Packing Systems, Inc. (Sps) | 1990-01-22 | 66 | 0 |
| K896321 | NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH. | Superior Healthcare Group, Inc. | 1989-11-13 | 12 | 0 |
| K894299 | REPRO-MED EMERGENCY AIRWAY VACUUM SYSTEM | Repro-Med Systems, Inc. | 1989-09-22 | 92 | 0 |
| K892529 | REPRO-MED NEONATE ASPIRATION SYSTEM | Repro-Med Systems, Inc. | 1989-06-12 | 62 | 0 |
| K893462 | NU-TRAP SUCTION CATHETER W/MUCUS TRAP | Atheus Corp. | 1989-06-08 | 36 | 0 |
| K893204 | MUC-X | Island Medical | 1989-06-01 | 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