FDA product code · General Hospital
KGXTape And Bandage, Adhesive
Product code KGX covers Tape And Bandage, Adhesive, a Class I device regulated under 21 CFR 880.5240. FDA has cleared 187 devices in this code. Median review time across the 187 most recent decisions is 84 days. openFDA lists 48 recall records against this code.
Updated · ingest status · JSON
- Class
- Class I
- Regulation
- 21 CFR 880.5240
- Review panel
- General Hospital
- Clearances
- 187
What is happening in KGX right now?
KGX (Tape And Bandage, Adhesive) has two findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-1180-2026, Z-1005-2026, Z-0898-2026, Z-0899-2026, Z-0900-2026). Adverse events reported in 2026-03 ran high — 47 reports against an expected 19 to 44 (KGX:MAUDE:2026-03).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-1180-2026, Z-1005-2026, Z-0898-2026, Z-0899-2026, Z-0900-2026 |
| Adverse-event spike | Serious | KGX:MAUDE:2026-03 |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in KGX?
FDA has cleared 187 devices under product code KGX since the 510(k) programme began in 1976.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K001240 | SERAGARD INJECTION PATCH | Platinum Services, Inc. | |
| K983368 | CARE BAND ANTIBACTERIAL BANDAGES | Aso Corp. | |
| K972914 | SYVEK PATCH | Marine Polymer Technologies, Inc. | |
| K943314 | ADHESIVE BANDAGES WITH OTC DRUG | Johnson & Johnson Consumer Products, Inc. | |
| K952606 | TARGETT PATCH | Cutting Edge Technologies, Inc. | |
| K954007 | PARALLEL | Johnson & Johnson Consumer Products, Inc. | |
| K944587 | DERMIVIEW HYPOALLERGENIC CLEAR TAPE | Johnson & Johnson Medical, Inc. | |
| K944588 | STERILE PLASTIC DRESSING | Smith & Nephew, Inc. | |
| K941788 | BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP | Johnson & Johnson Consumer Products, Inc. | |
| K940536 | BAND-AID(TM) BRAND ADHESIVE BANDAGE | Johnson & Johnson Consumer Products, Inc. |
How long does FDA review take for KGX?
The median FDA review time for KGX is 84 days, measured across the 187 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in KGX?
openFDA lists 48 recall records against product code KGX. A recall record covers one firm's corrective action and may span many device lots.
Z-1180-2026Open, ClassifiedGOLD STAR DISTRIBUTION INC
Potential exposure of rodents and rodent activity in the distribution center.
Z-1005-2026Open, ClassifiedFerndale Laboratories, Inc.
Butyrate tube cracks during actuation, rendering product unusable.
Z-0898-2026Open, ClassifiedMedline Industries, LP
Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.
Z-0899-2026Open, ClassifiedMedline Industries, LP
Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.
Z-0900-2026Open, ClassifiedMedline Industries, LP
Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.
Showing the 5 most recently initiated of 48. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for KGX?
MAUDE holds 803 adverse-event reports naming product code KGX, 250 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in KGX unusual?
3 months sit above KGX's own expected range: 1 April 2025, 1 May 2025, 1 March 2026.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 26 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 14 | Insufficient history | No expected range — too little history | |
| 18 | Insufficient history | No expected range — too little history | |
| 15 | Insufficient history | No expected range — too little history | |
| 19 | Insufficient history | No expected range — too little history | |
| 21 | Insufficient history | No expected range — too little history | |
| 14 | Insufficient history | No expected range — too little history | |
| 28 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 13 | Insufficient history | No expected range — too little history | |
| 16 | Insufficient history | No expected range — too little history | |
| 20 | Insufficient history | No expected range — too little history | |
| 24 | Insufficient history | No expected range — too little history | |
| 19 | Insufficient history | No expected range — too little history | |
| 21 | Insufficient history | No expected range — too little history | |
| 20 | Insufficient history | No expected range — too little history | |
| 19 | Insufficient history | No expected range — too little history | |
| 22 | Insufficient history | No expected range — too little history | |
| 12 | 9–28 | Within expected (9–28) | |
| 18 | 8–21 | Within expected (8–21) | |
| 24 | 10–24 | Within expected (10–24) | |
| 30 | 13–27 | Above expected (13–27) | |
| 33 | 13–30 | Above expected (13–30) | |
| 20 | 14–38 | Within expected (14–38) | |
| 35 | 19–57 | Within expected (19–57) | |
| 27 | 14–42 | Within expected (14–42) | |
| 35 | 15–44 | Within expected (15–44) | |
| 31 | 16–46 | Within expected (16–46) | |
| 18 | 15–41 | Within expected (15–41) | |
| 32 | 13–42 | Within expected (13–42) | |
| 34 | 16–50 | Within expected (16–50) | |
| 29 | 17–40 | Within expected (17–40) | |
| 47 | 19–44 | Above expected (19–44) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in KGX.
What are the predicate devices in KGX?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in KGX?
Across the 187 most recent decisions, these applicants filed most often in KGX.
| Applicant | Recent clearances |
|---|---|
| Beiersdorf, Inc. | 15 |
| Lectec Corp. | 8 |
| 3M Company | 6 |
| Avery Intl. | 6 |
| Convatec, A Division of E.R. Squibb & Sons | 6 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
Source: openFDA device/510k · retrieved
Watch KGX
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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.