Medical device manufacturer
Convatec Inc.
Convatec Inc. holds 112 FDA 510(k) clearances across 30 product codes. Median elapsed review time is 88 days. openFDA lists 71 recall records naming the company. FDA publishes it under 13 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 112
- Product codes
- 30
- Median review
- 88 days
- Recall records
- 71
How does FDA spell Convatec Inc.?
FDA publishes this company under 13 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 |
|---|---|---|
| CONVATEC LIMITED | device/registrationlisting | normalised |
| ConvaTec | device/recall | normalised |
| ConvaTec, Inc | device/enforcement | normalised |
| ConvaTec, Inc | device/recall | normalised |
| ConvaTec, Inc. | device/registrationlisting | normalised |
| Convatec | device/510k | normalised |
| Convatec Inc. | device/recall | normalised |
| Convatec Inc. | device/enforcement | normalised |
Showing 8 of 13.
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 Convatec Inc. file in?
30 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| FRO | Dressing, Wound, Drug | 23 | 89 days | |
| KMF | Bandage, Liquid | 13 | 86 days | |
| EXB | Collector, Ostomy | 9 | 59 days | |
| KGX | Tape And Bandage, Adhesive | 6 | 73 days | |
| EZD | Catheter, Straight | 5 | 168 days | |
| KNT | Tubes, Gastrointestinal (And Accessories) | 5 | 160 days | |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 5 | 50 days | |
| EYQ | Garment, Protective, For Incontinence | 4 | 30 days | |
| LRJ | Disinfectant, Medical Devices | 4 | 21 days | |
| NAD | Dressing, Wound, Occlusive | 4 | 21 days | |
| EXJ | Device, Incontinence, Urosheath Type, Sterile | 3 | 39 days | |
| EZQ | Pouch, Colostomy | 3 | 95 days | |
| FAQ | Bag, Urine Collection, Leg, For External Use, Sterile | 3 | 29 days | |
| KOD | Catheter, Urological | 3 | 109 days | |
| EXI | Device, Paste-On For Incontinence, Sterile | 2 | 38 days | |
| GBM | Catheter, Urethral | 2 | 101 days | |
| KGN | Wound Dressing With Animal-Derived Material(S) | 2 | 56 days | |
| KNY | Accessories, Catheter, G-U | 2 | 15 days | |
| MCY | Wound Dressing Kit | 2 | 97 days | |
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | 2 | 78 days | |
| EXD | Irrigator, Ostomy | 1 | 44 days | |
| EXE | Protector, Ostomy | 1 | 182 days | |
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | 1 | 73 days | |
| JOW | Sleeve, Limb, Compressible | 1 | 252 days | |
| KMK | Device, Intravascular Catheter Securement | 1 | 324 days |
Showing the 25 they file in most, of 30.
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 Convatec Inc. had a recall?
openFDA lists 71 recall records naming this company across its whole history, of which 5 were opened in the last 12 months and are not yet marked terminated. A recall record covers one firm's corrective action and may span many device lots.
Z-2677-2026Class IIOpen, ClassifiedFRO
Surgical dressing manufactured out of specification (greater thickness).
Z-1582-2026Class IIOpen, ClassifiedFON
Drainable large pouch may leak due to manufacturing issue.
Z-1583-2026Class IIOpen, ClassifiedFON
Drainable large pouch may leak due to manufacturing issue.
Z-1584-2026Class IIOpen, ClassifiedFON
Drainable large pouch may leak due to manufacturing issue.
Z-0160-2026Class IIOpen, ClassifiedNAD
Wound dressing may have foreign matter on the product.
Showing the 5 most recently initiated of 71.
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 Convatec Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K252943 | GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women | EZD | 198 | |
| K250699 | Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit with supplies (T8K); Cure Twist Female 10 Catheter Kit with supplies (T10K); Cure Twist Female 12 Catheter Kit with supplies (T12K); Cure Twist Female 14 Catheter Kit with supplies (T14K); Cure Twist Female 16 Catheter Kit with supplies (T16K) | EZD | 116 | |
| K250891 | Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C | FCM | 73 | |
| K243228 | Flexi-Seal AIR (with ENFit Connector) | KNT | 171 | |
| K232665 | GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14) | EZD | 147 | |
| K230400 | Cure Catheter Closed System; Cure Dextra Closed System | EZD | 266 | |
| K221593 | Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus | EZD | 168 | |
| K213283 | GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter | GBM | 264 | |
| K190114 | Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) | KNT | 96 | |
| K180205 | AVELLE Negative Pressure Wound Therapy System | OMP | 268 |
Source: openFDA device/510k · retrieved
Where is Convatec Inc. registered?
FDA lists 2 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 Convatec Inc. 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.