Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
3M Health Care, Ltd. — Predicate Candidate Screening
49 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
222 daysmedian FDA review time
365 days90th percentile
49clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K953904 | SARNS 9000 UNIVERSAL ROLLER PUMP | 3M Health Care, Ltd. | 1996-04-19 | 245 | 3 |
| K926364 | ATTEST BRAND RAPID READOUT BIOLOGICAL IND. #129X | 3M Health Care, Ltd. | 1995-03-31 | 829 | 0 |
| K941534 | MODULAR VS-22 CEMENTED FEMORAL HIP SYSTEM | 3M Health Care, Ltd. | 1995-03-06 | 341 | 0 |
| K941748 | STERI-VAC GAS STERILIZER MODEL 8XL | 3M Health Care, Ltd. | 1994-12-02 | 238 | 2 |
| K930681 | 3M PREVENTION FABRIC SURGICAL GOWN #78XX | 3M Health Care, Ltd. | 1994-02-10 | 365 | 0 |
| K932307 | 3M MAXI-DRIVER II DBATTERY POWERED SYSTEM | 3M Health Care, Ltd. | 1994-01-07 | 241 | 0 |
| K932422 | 3M TEGADERM HP TRANSPARENT DRESSING | 3M Health Care, Ltd. | 1993-12-27 | 222 | 0 |
| K932446 | INJECTION SITE | 3M Health Care, Ltd. | 1993-11-29 | 193 | 0 |
| K931968 | CDI 100 EXTRACORPOREAL HEMATOCRIT/OXYGEN SATURATIO | 3M Health Care, Ltd. | 1993-11-10 | 203 | 0 |
| K933005 | AVI MODEL 600 SYRINGE PUMP | 3M Health Care, Ltd. | 1993-10-25 | 126 | 0 |
| K933006 | AVI INFUSION PUMPS, ADDITIONAL INTENDED USE | 3M Health Care, Ltd. | 1993-10-25 | 126 | 0 |
| K930312 | 3M RED DOT 2234 RADIOLUCENT MONITORING ELECTRODE | 3M Health Care, Ltd. | 1993-09-01 | 222 | 0 |
| K926059 | 3M MODEL 200RT RATE TAPER INFUSION PUMP | 3M Health Care, Ltd. | 1993-08-16 | 258 | 0 |
| K932454 | 3M RED DOT 2330 RESTING EKG ELECTRODE | 3M Health Care, Ltd. | 1993-08-16 | 87 | 0 |
| K926058 | 3M MODEL 280RT RATE TAPER INFUSION PUMP | 3M Health Care, Ltd. | 1993-08-16 | 258 | 0 |
| K930468 | 3M INCONTINENCE BARRIER FILM, PRODUCT SERIES 336X | 3M Health Care, Ltd. | 1993-08-06 | 190 | 0 |
| K915363 | SARNS 7850 CENTRIFUGAL PUMP (MODIFIED) | 3M Health Care, Ltd. | 1993-07-28 | 609 | 1 |
| K920362 | 3M MODULAR SHOULDER SYSTEM | 3M Health Care, Ltd. | 1993-07-22 | 541 | 0 |
| K931604 | 3M MEDICAL DIAGNOSTIC VIDEOCASSETTE | 3M Health Care, Ltd. | 1993-07-21 | 111 | 0 |
| K931605 | 3M MEDICAL DIAGNOSTIC SUPER VHS VIDEOCASSETTE | 3M Health Care, Ltd. | 1993-07-20 | 110 | 0 |
| K924871 | MODEL 880 INFUSION PUMP, MODIFICATION | 3M Health Care, Ltd. | 1993-06-18 | 268 | 0 |
| K924869 | MODEL 480CM INFUSION PUMP, MODIFICATION | 3M Health Care, Ltd. | 1993-06-17 | 267 | 0 |
| K924872 | MODEL 885 INFUSION PUMP, MODIFICATION | 3M Health Care, Ltd. | 1993-06-17 | 267 | 0 |
| K924866 | MODEL 285CM INFUSION PUMP, MODIFICATION | 3M Health Care, Ltd. | 1993-06-17 | 267 | 0 |
| K924868 | MODEL 480 INFUSION PUMP, MODIFICATION | 3M Health Care, Ltd. | 1993-06-17 | 267 | 0 |
| K924867 | 285CI INFUSION PUMP, MODIFICATION | 3M Health Care, Ltd. | 1993-06-17 | 267 | 0 |
| K924865 | MODEL 285 INFUSION PUMP, MODIFICATION | 3M Health Care, Ltd. | 1993-06-17 | 267 | 0 |
| K924870 | MODEL 480CI INFUSION PUMP, MODIFICATION | 3M Health Care, Ltd. | 1993-06-17 | 267 | 0 |
| K924207 | AVI(TM) MODEL 232 STANDARD IV ADMINISTRATION SET | 3M Health Care, Ltd. | 1993-05-26 | 279 | 0 |
| K921925 | MANUAL SURGICAL INSTRUMENTS | 3M Health Care, Ltd. | 1993-05-26 | 397 | 0 |
| K924280 | 3M TEGASORB THIN HYDROCOLLOID DRESSING | 3M Health Care, Ltd. | 1993-05-12 | 260 | 0 |
| K923068 | AVI MODEL 3100 INFUSION PUMP | 3M Health Care, Ltd. | 1993-04-20 | 299 | 0 |
| K925618 | 3M REMOVER LOTION PRODUCT NUMBER 86XX | 3M Health Care, Ltd. | 1993-03-31 | 145 | 0 |
| K924487 | RED DOT 2515 CARDIAC SENSOR SYSTEM | 3M Health Care, Ltd. | 1992-12-23 | 111 | 0 |
| K920009 | 3M LITTMANN GRAPHIC DISPLAY SYSTEM | 3M Health Care, Ltd. | 1992-10-21 | 293 | 0 |
| K922992 | CONDUCER CARDIOPLEGIA SET SITH MP4 | 3M Health Care, Ltd. | 1992-09-18 | 88 | 1 |
| K920794 | BRND SKIN PROTECTION PREP SERIES 33XX | 3M Health Care, Ltd. | 1992-08-10 | 171 | 0 |
| K921051 | 3M PRECISE BRAND INTERNAL SURGICAL STAPLES | 3M Health Care, Ltd. | 1992-07-16 | 133 | 0 |
| K921073 | AVI MODEL 480CI INFUSION PUMP | 3M Health Care, Ltd. | 1992-05-26 | 81 | 0 |
| K921072 | AVI MODEL 470CI INFUSION PUMP | 3M Health Care, Ltd. | 1992-05-26 | 81 | 0 |
| K920681 | AVI MODEL 285CI INFUSION PUMP | 3M Health Care, Ltd. | 1992-04-06 | 52 | 0 |
| K920680 | AVI MODEL 275CI INFUSION PUMP | 3M Health Care, Ltd. | 1992-04-06 | 52 | 0 |
| K920588 | AVI MODEL 3000 INFUSION PUMP | 3M Health Care, Ltd. | 1992-04-06 | 56 | 0 |
| K912915 | SARNS NON-FILTERED VENOUS RESERVOIR | 3M Health Care, Ltd. | 1991-09-25 | 84 | 0 |
| K912920 | SARNS SM03 MEMBRANE OXYGENATOR W/ INTEGRATED RESER | 3M Health Care, Ltd. | 1991-09-25 | 84 | 0 |
| K912871 | INSIDE JOB | 3M Health Care, Ltd. | 1991-08-09 | 42 | 1 |
| K912520 | 3M WATER DISPERSIBLE ADHESIVE TAPE, 98XX | 3M Health Care, Ltd. | 1991-07-26 | 50 | 0 |
| K904921 | STERI-VAC(TM) AERATOR MODEL XL | 3M Health Care, Ltd. | 1990-12-05 | 35 | 0 |
| K902654 | CDI (TM) SYSTEM 100 MONITORING SYSTEM | 3M Health Care, Ltd. | 1990-11-05 | 143 | 5 |
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