Medical device manufacturer
Kimberly-Clark Corporation
Kimberly-Clark Corporation holds 122 FDA 510(k) clearances across 35 product codes. Median elapsed review time is 68 days. openFDA lists 35 recall records naming the company. FDA publishes it under 9 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 122
- Product codes
- 35
- Median review
- 68 days
- Recall records
- 35
How does FDA spell Kimberly-Clark Corporation?
FDA publishes this company under 9 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| KIMBERLY-CLARK CORPORATION | device/registrationlisting | normalised |
| Kimberly Clark Corporation | device/510k | normalised |
| Kimberly-Clark | device/510k | normalised |
| Kimberly-Clark Corp. | device/510k | normalised |
| Kimberly-Clark Corporation | device/registrationlisting | normalised |
| Kimberly-Clark Corporation | device/enforcement | normalised |
| Kimberly-Clark Corporation | device/recall | normalised |
| Kimberly-Clark Corporation | device/510k | normalised |
Showing 8 of 9.
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Kimberly-Clark Corporation file in?
35 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| HEB | Tampon, Menstrual, Unscented | 16 | 30 days | |
| HHD | Pad, Menstrual, Unscented | 13 | 57 days | |
| FYA | Gown, Surgical | 12 | 97 days | |
| FRG | Wrap, Sterilization | 11 | 125 days | |
| LZA | Polymer Patient Examination Glove | 11 | 87 days | |
| KKX | Drape, Surgical, Antimicrobial | 8 | 36 days | |
| HHL | Pad, Menstrual, Scented, Scented-Deodorized | 7 | 45 days | |
| BTR | Tube, Tracheal (W/Wo Connector) | 4 | 110 days | |
| FXX | Mask, Surgical | 4 | 80 days | |
| KME | Bedding, Disposable, Medical | 3 | 35 days | |
| EYQ | Garment, Protective, For Incontinence | 2 | 33 days | |
| FYF | Cap, Surgical | 2 | 27 days | |
| KGC | Tube, Gastro-Enterostomy | 2 | 26 days | |
| KNT | Tubes, Gastrointestinal (And Accessories) | 2 | 30 days | |
| LZC | Medical Glove, Specialty | 2 | 43 days | |
| OXZ | Pediatric/Child Facemask | 2 | 172 days | |
| BSO | Catheter, Conduction, Anesthetic | 1 | 29 days | |
| BWP | Shoe And Shoe Cover, Conductive | 1 | 147 days | |
| DWJ | System, Thermal Regulating | 1 | 47 days | |
| DWL | Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | 1 | 53 days | |
| FME | Gown, Examination | 1 | 22 days | |
| FXO | Suit, Surgical | 1 | 34 days | |
| FXP | Cover, Shoe, Operating-Room | 1 | 15 days | |
| FYC | Gown, Isolation, Surgical | 1 | 59 days | |
| HHT | Spatula, Cervical, Cytological | 1 | 112 days |
Showing the 25 they file in most, of 35.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Kimberly-Clark Corporation had a recall?
openFDA lists 35 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.
Z-0748-2019Class IITerminatedHEB
Potential for tampon to come apart upon removal.
Z-0749-2019Class IITerminatedHEB
Potential for tampon to come apart upon removal.
Z-0750-2019Class IITerminatedHEB
Potential for tampon to come apart upon removal.
Z-0751-2019Class IITerminatedHEB
Potential for tampon to come apart upon removal.
Z-0850-2014Class IITerminatedGXI
Product may contain a cannula with an active tip length of only 5mm rather than 10mm as indicated on the label.
Showing the 5 most recently initiated of 35.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Kimberly-Clark Corporation cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K231435 | KIMTECH Polaris Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid | LZA | 103 | |
| K231021 | KIMTECH Polaris Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid | LZA | 102 | |
| K223749 | U by Kotex® Click® Unscented Menstrual Tampons | HEB | 23 | |
| K202416 | Kimtech Prizm Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid, Kimtech Prizm Xtra Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid | LZA | 98 | |
| K200072 | KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl, Gastric acid, and Fentanyl in Gastric acid | LZA | 87 | |
| K172118 | U by Kotex Click Unscented Menstrual Tampons | HEB | 90 | |
| K143164 | ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set | BSO | 29 | |
| K140963 | KIMGUARD SMART-FOLD STERILIZATION WRAP | FRG | 209 | |
| K141294 | U BY KOTEX SECURITY UNSCENTED MENSTRUAL TAMPONS | HEB | 98 | |
| K140539 | AERO BLUE PERFORMANCE SURGICAL GOWN | FYA | 97 |
Source: openFDA device/510k · retrieved
Where is Kimberly-Clark Corporation registered?
FDA lists 3 registered establishments for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Kimberly-Clark Corporation files next
Get an email when this company clears a new device, or when anything is recalled in a product code you follow.
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.