Sage Products, Inc.: FDA filings under this applicant name
FDA lists 31 510(k) clearances under the applicant name “Sage Products, Inc.” (first 1978, latest 1998), across 18 product codes in 6 review panels. Median 510(k) review time under this name: 49 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Stryker, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MMK | Container, Sharps | 5 | 5 |
| FMH | Container, Specimen, Sterile | 4 | 4 |
| FMI | Needle, Hypodermic, Single Lumen | 4 | 4 |
| LIO | Device, Specimen Collection | 3 | 3 |
| KDT | Container, Specimen Mailer And Storage, Sterile | 2 | 2 |
| BTX | Board, Arm (With Cover), Sterile | 1 | 1 |
| EIA | Unit, Operative Dental | 1 | 1 |
| FMT | Warmer, Infant Radiant | 1 | 1 |
| FXX | Mask, Surgical | 1 | 1 |
| FYC | Gown, Isolation, Surgical | 1 | 1 |
Plus 8 more product codes.
Review panels
- General Hospital (19)
- Microbiology (4)
- Gastroenterology and Urology (2)
- Pathology (2)
- General and Plastic Surgery (2)
- Dental (1)
Most recent Sage Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K972705 | RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC | FMI | 1998-04-30 | 283 |
| K980490 | SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPS | MMK | 1998-02-24 | 15 |
| K973911 | 2 GALLON ALTERNATE CARE SHARPS CONTAINER | FMI | 1997-10-29 | 15 |
| K972279 | SHARPS SHUTTLE | FMI | 1997-08-29 | 72 |
| K970135 | NITRILE GLOVES | LZC | 1997-08-25 | 222 |
| K972302 | POCKET COUNT OR SAFETCOUNT | LWH | 1997-07-25 | 36 |
| K964168 | PROCEDURE SPECIFIC KITS | FXX | 1997-03-03 | 137 |
| K963986 | STP SYSTEM PVA WITH ZINC | LIO | 1996-11-08 | 35 |
| K964026 | STP SYSTEM - SAF | LIO | 1996-11-07 | 31 |
| K964027 | STP SYSTEM-PVA WITH MERCURY | LIO | 1996-11-01 | 25 |
21 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 1 initiated in the last five years. Most recent: 2023-10-23.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Sage Biopharma (6 510(k)s)
- Sage In-Vitro Fertilization, Inc. (2 510(k)s)
- Sage Pharmaceuticals, Inc. (2 510(k)s)
- Sage Electronics Products, Inc. (1 510(k)s)
- Sage Laboratories, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sage Products, Inc.?
FDA lists 31 510(k) clearances under the applicant name “Sage Products, Inc.” (first 1978, latest 1998), across 18 product codes in 6 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Sage Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sage Products, Inc. is 49 days.
Which FDA product codes appear under Sage Products, Inc.?
The most frequent FDA product codes under this applicant name are MMK (Container, Sharps, 5); FMH (Container, Specimen, Sterile, 4); FMI (Needle, Hypodermic, Single Lumen, 4).
Next steps
- See all 31 Sage Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MMK, Sage Products, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.