Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sage Products, Inc. — Predicate Candidate Screening
31 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
49 daysmedian FDA review time
238 days90th percentile
31clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972705 | RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER | Sage Products, Inc. | 1998-04-30 | 283 | 0 |
| K980490 | SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP | Sage Products, Inc. | 1998-02-24 | 15 | 0 |
| K973911 | 2 GALLON ALTERNATE CARE SHARPS CONTAINER | Sage Products, Inc. | 1997-10-29 | 15 | 0 |
| K972279 | SHARPS SHUTTLE | Sage Products, Inc. | 1997-08-29 | 72 | 0 |
| K970135 | NITRILE GLOVES | Sage Products, Inc. | 1997-08-25 | 222 | 0 |
| K972302 | POCKET COUNT OR SAFETCOUNT | Sage Products, Inc. | 1997-07-25 | 36 | 0 |
| K964168 | PROCEDURE SPECIFIC KITS | Sage Products, Inc. | 1997-03-03 | 137 | 0 |
| K963986 | STP SYSTEM PVA WITH ZINC | Sage Products, Inc. | 1996-11-08 | 35 | 0 |
| K964026 | STP SYSTEM - SAF | Sage Products, Inc. | 1996-11-07 | 31 | 0 |
| K964027 | STP SYSTEM-PVA WITH MERCURY | Sage Products, Inc. | 1996-11-01 | 25 | 0 |
| K962168 | MUCUS SPECIMEN TRAP | Sage Products, Inc. | 1996-07-22 | 47 | 0 |
| K943658 | CHEMOTHERAPY WASTE DISPOSAL CONTAINERS | Sage Products, Inc. | 1995-03-22 | 238 | 0 |
| K943660 | PHLEBOTOMY SHARPS DISPOSAL CONTAINERS | Sage Products, Inc. | 1995-03-22 | 238 | 0 |
| K943659 | ANCILLARY AND LARGE VOLUME SHARPS DISPOSAL CONTAINERS | Sage Products, Inc. | 1995-03-22 | 238 | 0 |
| K941991 | IN-ROOM AND SHARPSTAR | Sage Products, Inc. | 1994-08-29 | 126 | 0 |
| K933370 | STOOL TRANSPORT/PROCESSOR | Sage Products, Inc. | 1994-02-17 | 223 | 0 |
| K901806 | SUCTION ORA-SWAB(R) BRUSH KIT | Sage Products, Inc. | 1990-08-15 | 117 | 0 |
| K894064 | STERILE HAND COVER | Sage Products, Inc. | 1989-08-11 | 64 | 0 |
| K874888 | ISOLATION GOWN | Sage Products, Inc. | 1987-12-30 | 29 | 0 |
| K873569 | BLOOD NEEDLE HOLDER | Sage Products, Inc. | 1987-11-03 | 62 | 0 |
| K823413 | MOUTH CARE KIT W/TOOTHBRUSH | Sage Products, Inc. | 1983-03-29 | 134 | 0 |
| K823411 | PEDIATRIC URINE COLLECTOR | Sage Products, Inc. | 1982-12-28 | 43 | 0 |
| K823412 | ARM BOARD W/I.V COVERING | Sage Products, Inc. | 1982-12-15 | 30 | 0 |
| K820246 | PREFILLED SPECIMEN CONTAINER | Sage Products, Inc. | 1982-02-18 | 20 | 0 |
| K813408 | SAGE 2200 STERILE SPECIMEN CONTAINER | Sage Products, Inc. | 1982-01-25 | 49 | 0 |
| K800946 | URINARY CATHETER SAMPLING KIT | Sage Products, Inc. | 1980-06-20 | 59 | 0 |
| K800947 | MIDSTREAM COLLECTION KIT | Sage Products, Inc. | 1980-05-30 | 38 | 0 |
| K800397 | ELLIK BLADDER EVACUATOR | Sage Products, Inc. | 1980-03-10 | 13 | 0 |
| K800309 | SPECIMEN COLLECTION PAN | Sage Products, Inc. | 1980-02-26 | 14 | 0 |
| K790291 | OPERATING ROOM SPECIMEN CONTAINER | Sage Products, Inc. | 1979-04-10 | 61 | 0 |
| K781557 | 24-HOUR URINE COLLECTION COOLING WRAP | Sage Products, Inc. | 1978-10-17 | 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