Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MEB — Predicate Candidate Screening
88 FDA 510(k) clearances under this product code; the 50 most recent screened below.
88 daysmedian FDA review time
261 days90th percentile
88clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250234 | SMARTeZ™ Elastomeric Infusion Pump (RS series) | Epic Medical Pte. , Ltd. | 2026-04-24 | 452 | 0 |
| K240624 | InfuLife | First Medical Source, LLC | 2024-11-05 | 245 | 0 |
| K242152 | SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, | Epic Medical Pte. , Ltd. | 2024-10-07 | 76 | 0 |
| K181360 | ON-Q* Pump with Bolus | Halyard Health | 2019-03-22 | 304 | 0 |
| K151650 | SMARTez elastomeric infusion pump | Epic Medical Pte. , Ltd. | 2016-04-04 | 291 | 0 |
| K131249 | ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-S | I-Flow, LLC | 2014-02-03 | 278 | 0 |
| K131247 | MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM | Mfs - Medical Flow Systems, Ltd. | 2013-08-14 | 105 | 0 |
| K090300 | MODIFICATION TO AUTOFUSER | Ace Medical Us, LLC | 2009-04-30 | 83 | 0 |
| K081905 | ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP | Westmed, Inc. | 2008-07-15 | 12 | 7 |
| K071532 | ALPHA INFUSION PUMP, MODEL A200, A450 | Advanced Infusion, Inc. | 2008-02-19 | 259 | 0 |
| K072921 | DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM | Symbios Medical Products, LLC | 2007-11-26 | 42 | 1 |
| K072053 | SMARTBLOCK PAIN PUMP | Medical Flow Systems, Ltd. | 2007-11-06 | 103 | 2 |
| K071735 | MODIFICATION TO DISPOSABLE INFUSION PUMP KIT | Symbios Medical Products, LLC | 2007-07-19 | 23 | 0 |
| K071222 | INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES | Baxter Healthcare Corp | 2007-05-25 | 23 | 4 |
| K063530 | ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, | I-Flow Corp. | 2007-01-26 | 65 | 3 |
| K061661 | STA CATH ATTACHABLE INFISION CATHETER, MODEL STA20 | Advanced Infusion, Inc. | 2006-10-18 | 127 | 0 |
| K062457 | INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES | Baxter Healthcare Corporation | 2006-09-21 | 29 | 2 |
| K061409 | SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N | Precise Medical Products, Ltd. | 2006-06-16 | 25 | 2 |
| K060258 | AUTOFUSER | Ace Medical Us, LLC | 2006-05-30 | 118 | 46 |
| K060933 | SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM | Apex Medical Technologies, Inc. | 2006-05-09 | 34 | 0 |
| K052999 | SEMPERFLO INFUSION SYSTEM | ETHICON, Inc. | 2006-03-22 | 148 | 0 |
| K051828 | NIPRO SUREFUSER AMBULATORY INFUSION PUMP | Nipro Medical Corporation | 2005-12-15 | 162 | 0 |
| K052451 | MPS ACACIA MEDFLO ELASTOMERIC PUMP | Mps Acacia | 2005-12-08 | 92 | 0 |
| K052117 | I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP | I-Flow Corp. | 2005-09-09 | 36 | 3 |
| K051474 | SYMBIOS DISPOSABLE INFUSION PUMP KIT | Symbios Medical Products, LLC | 2005-07-01 | 28 | 0 |
| K050770 | MODIFICATION TO ACCUFUSER, ACCUFUSER PLUS STANDARD PROCEDURE | Mckinley Medical, LLC | 2005-04-14 | 20 | 0 |
| K042122 | SMARTINFUSER PAINPUMP | Precise Medical Products | 2004-09-22 | 47 | 1 |
| K042246 | MULTI-DRIP INFUSION CATHETER | Advanced Infusion, Inc. | 2004-08-31 | 12 | 0 |
| K041585 | AUTOFUSER AMBULATORY INFUSION PUMP | Algos, LC | 2004-08-26 | 73 | 46 |
| K040337 | I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP) | I-Flow Corp. | 2004-05-24 | 103 | 0 |
| K040752 | DOSI-FUSER | Leventon, S.A. | 2004-04-07 | 14 | 0 |
| K033039 | MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDU | Mckinley, Inc. | 2003-10-07 | 8 | 0 |
| K030830 | B. BRAUN NERVE BLOCK CATHETER | B.Braun Medical, Inc. | 2003-07-15 | 123 | 0 |
| K023883 | HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYP | I-Flow Corp. | 2002-12-20 | 29 | 0 |
| K023098 | ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KIT, ACCUFUSER | Mckinley Infuser | 2002-12-09 | 82 | 0 |
| K023318 | I-FLOW ELASTOMERIC PUMP WITH BOLUS | I-Flow Corp. | 2002-10-18 | 14 | 1 |
| K021964 | ALPHA INFUSION PUMP AND CATHETERS | Advanced Infusion, Inc. | 2002-08-12 | 59 | 0 |
| K021274 | PAIN-MATE PAIN MANAGEMENT SYSTEM WITH DUAL PORT 1+1, 2+2, MO | Baxter Healthcare Corp | 2002-05-17 | 25 | 0 |
| K020988 | PAIN CARE 4200 | Breg, Inc. | 2002-04-04 | 8 | 0 |
| K020862 | I-FLOW ELASTOMERIC PUMP | I-Flow Corp. | 2002-03-26 | 8 | 1 |
| K020660 | HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYP | I-Flow Corp. | 2002-03-20 | 19 | 0 |
| K013928 | PAIN CARE 3200 | Breg, Inc. | 2001-12-03 | 5 | 0 |
| K011117 | MPS ACACIA MEDFLO INFUSION (LI) AND MPS ACACIA MEDFLO INFUSI | Mps Acacia | 2001-07-09 | 88 | 0 |
| K011317 | MULTIRATE INFUSOR SV; MULTIRATE INFUSER LV; BAXTER PAIN MATE | Baxter Healthcare Corp | 2001-06-28 | 59 | 1 |
| K010824 | PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT | Science Incorporated | 2001-06-05 | 78 | 0 |
| K003915 | ACCUFUSER; ACCUFUSER PLUS | Help Technologies | 2001-02-15 | 58 | 0 |
| K003476 | MPS ACACIA PAIN KIT | Mps Acacia | 2001-01-12 | 64 | 0 |
| K002073 | PAIN CARE 3000 | Breg, Inc. | 2000-09-19 | 71 | 0 |
| K001342 | P.O.P. PAIN KIT | Post Operative Pain Management | 2000-09-07 | 133 | 0 |
| K002321 | PAIN CARE 2000L | Breg, Inc. | 2000-08-14 | 14 | 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