Kimberly-Clark Health Care: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Kimberly-Clark Health Care” (first 2013, latest 2015), across 1 product code in 1 review panel. Median 510(k) review time under this name: 162 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 1 | 606 |
| 2014 | 2 | 73 |
| 2015 | 2 | 163 |
| 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 |
|---|---|---|---|
| FRG | Wrap, Sterilization | 5 | 5 |
Review panels
- General Hospital (5)
Most recent Kimberly-Clark Health Care 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K143053 | KIMGUARD ONE-STEP Sterilization Wrap | FRG | 2015-04-03 | 162 |
| K142782 | KIMGUARD ONE-STEP Sterilization Wrap | FRG | 2015-03-09 | 164 |
| K141612 | KIMGUARD ONE-STEP STERILIZATION WRAP | FRG | 2014-08-07 | 52 |
| K141071 | KIMGUARD ONE-STEP STERILIZATION WRAP | FRG | 2014-07-28 | 94 |
| K113806 | KIMGUARD ONE STEP STERILIZATION WRAP | FRG | 2013-08-20 | 606 |
Recalls
openFDA lists no recalls under a recalling firm named Kimberly-Clark Health Care.
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.
- Kimberly-Clark Corp. (122 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Kimberly-Clark Health Care?
FDA lists 5 510(k) clearances under the applicant name “Kimberly-Clark Health Care” (first 2013, latest 2015), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Kimberly-Clark Health Care?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kimberly-Clark Health Care is 162 days.
Which FDA product codes appear under Kimberly-Clark Health Care?
The most frequent FDA product codes under this applicant name are FRG (Wrap, Sterilization, 5).
Next steps
- See all 5 Kimberly-Clark Health Care clearances with predicates and recalls
- Run predicate analysis for product code FRG, Kimberly-Clark Health Care'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.