Data / Medical devices / United States / Safe N Simple LLC
Safe N Simple LLC: FDA-registered device maker in Clarkston, MI, United States, 12 510(k) clearances
Safe N Simple LLC is registered with the FDA (registration 3008374791) in Clarkston, MI, United States. It lists 15 device types. The FDA files 12 510(k) clearances under its listings, the newest dated June 3, 2026. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3008374791
- Address
- 5827 Terex, Clarkston, MI, United States, 48346
- Owner or operator
- Safe N Simple LLC (10033201)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- December 4, 2012
- Registered through
- 2026
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 3, 2026 | K253974 | Roosin Collagen Dressing | KGN | Substantially Equivalent | Roosin Medical Co., Ltd. | accessdata.fda.gov |
| May 24, 2024 | K233111 | ALGS2 Ag Alginate Wound Dressing Rx; ALGS2 Ag Alginate Wound Dressing OTC; ALGS2S Re-enforced Ag Alginate Wound Dressing Rx; ALGS2S Re-enforced Ag Alginate Wound Dressing OTC | FRO | Substantially Equivalent | Foshan United Medical Technologies, Ltd. | accessdata.fda.gov |
| September 13, 2019 | K181478 | Roosin Xeroform Petrolatum Dressing | FRO | Substantially Equivalent | Roosin Medical Co., Ltd. | accessdata.fda.gov |
| February 14, 2019 | K181315 | Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing | FRO | Substantially Equivalent | Winner Medical Co., Ltd. | accessdata.fda.gov |
| March 30, 2017 | K170077 | LUOFUCON Silicone Ag Foam Dressing with Border | FRO | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| August 17, 2016 | K160022 | LUOFUCON Silicone Ag foam dressing | FRO | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| June 10, 2016 | K160095 | Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial Wound & Skin Cleanser 8oz, Simple Science Antimicrobial Wound & Skin Cleanser 16oz, Simple Science Antimicrobial Wound & Skin Cleanser 23oz | FRO | Substantially Equivalent | Simple Science, LLC | accessdata.fda.gov |
| June 1, 2015 | K143335 | Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC) | FRO | Substantially Equivalent | Roosin Medical Devices Co., Ltd. | accessdata.fda.gov |
| March 23, 2015 | K140954 | LUOFUCON SILVER PU ANTIBACTERIAL FOAM DRESSING | FRO | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| February 14, 2013 | K120181 | LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM | FRO | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| October 26, 2012 | K122325 | SKINTEMP II | KGN | Substantially Equivalent | Human Biosciences, Inc. | accessdata.fda.gov |
| May 20, 2011 | K102946 | CORELEADER COLLA-PAD MODEL CS 03030 | KGN | Substantially Equivalent | Coreleader Biotech Co., Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 22, 2018 | 81150 | Class II | Terminated | Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING, 4" X 5", 10 Pads, Catalogue number SNS58315 | The sterilization process used was unqualified. | accessdata.fda.gov |
| December 14, 2017 | 80234 | Class II | Terminated | DermaPro Waterproof Silicone Tape, SNS57232 | The recalling firm received a customer complaint stating the tape was difficult to peel off the roll and had poor adhesion. | accessdata.fda.gov |
| June 18, 2012 | 80232 | Class II | Terminated | Safe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, SNS00807 | The firm received a customer complaint of observed spots on the wipes. The manufacturer confirmed that the product had bacterial contamination. This leads to a potential risk of infection. | accessdata.fda.gov |
Compare with other makers
- All makers of Wound Dressing With Animal-Derived Material(S)
- All makers of Dressing, Wound, Drug
- All makers of Elastomer, Silicone, For Scar Management
- All makers of Dressing, Wound, Hydrogel Without Drug And/Or Biologic
- All makers of Dressing, Wound, Occlusive
- All makers of Burn Kit Without Drug
Updated June 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.