FDA product code · Gastroenterology, Urology
KDIDialyzer, High Permeability With Or Without Sealed Dialysate System
Product code KDI covers Dialyzer, High Permeability With Or Without Sealed Dialysate System, a Class II device regulated under 21 CFR 876.5860. FDA has cleared 345 devices in this code, 7 of them in the last 12 months. Median review time across the 345 most recent decisions is 125 days. openFDA lists 216 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 876.5860
- Review panel
- Gastroenterology, Urology
- Clearances
- 345
What is happening in KDI right now?
KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2702-2026, Z-1224-2026, Z-1225-2026, Z-1226-2026, Z-1227-2026). 1 first-time filer in the last 12 months, Medica USA, Inc (K243920). The code is crowded, scoring 71 of 100 — 77 companies hold a clearance here and 7 arrived in the last 12 months (KDI:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2702-2026, Z-1224-2026, Z-1225-2026, Z-1226-2026, Z-1227-2026 |
| New entrant | Worth knowing | K243920 |
| Crowding | Context | KDI:crowding |
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 KDI?
FDA has cleared 345 devices under product code KDI since the 510(k) programme began in 1976, 7 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261267 | Careflux H60;Careflux H70;Careflux V500 | Fresenius Medical Care Renal Therapies Group, LLC | |
| K252377 | NxStage System One with NxView | Fresenius Medical Care Renal Therapies Group, LLC | |
| K260533 | ELISIO-H | Nipro Medical Corporation | |
| K252459 | multiFlux 130 (F00013123); multiFlux 160 (F00013124) | Fresenius Medical Care Renal Therapies Group, LLC | |
| K253412 | Tablo Hemodialysis System (PN-0008000, PN-0006000U) | Outset Medical, Inc. | |
| K253518 | FX CorAL 40; FX CorAL 50 | Fresenius Medical Care Renal Therapies Group, LLC | |
| K243920 | Purema H Hemoconcentrator - Pediatric | Medica USA, Inc. | |
| K250508 | AK 98 Dialysis Machine (955607) | Vantive US Healthcare, LLC | |
| K243237 | 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128); 2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130) | Fresenius Medical Care Renal Therapies Group, LLC | |
| K243505 | 5008X Hemodialysis System | Fresenius Medical Care Renal Therapies Group, LLC |
How long does FDA review take for KDI?
The median FDA review time for KDI is 125 days, measured across the 345 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 KDI?
openFDA lists 216 recall records against product code KDI. A recall record covers one firm's corrective action and may span many device lots.
Z-2702-2026Open, ClassifiedFresenius Medical Care Holdings, Inc. dba Renal Solutions
Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.
Z-1224-2026Open, ClassifiedVantive US Healthcare LLC
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Z-1225-2026Open, ClassifiedVantive US Healthcare LLC
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Z-1226-2026Open, ClassifiedVantive US Healthcare LLC
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Z-1227-2026Open, ClassifiedVantive US Healthcare LLC
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Showing the 5 most recently initiated of 216. 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 KDI?
MAUDE holds 7,881 adverse-event reports naming product code KDI, 1,857 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 KDI unusual?
2 months sit above KDI's own expected range: 1 January 2025, 1 October 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 191 | Insufficient history | No expected range — too little history | |
| 203 | Insufficient history | No expected range — too little history | |
| 256 | Insufficient history | No expected range — too little history | |
| 193 | Insufficient history | No expected range — too little history | |
| 242 | Insufficient history | No expected range — too little history | |
| 222 | Insufficient history | No expected range — too little history | |
| 176 | Insufficient history | No expected range — too little history | |
| 284 | Insufficient history | No expected range — too little history | |
| 194 | Insufficient history | No expected range — too little history | |
| 214 | Insufficient history | No expected range — too little history | |
| 201 | Insufficient history | No expected range — too little history | |
| 233 | Insufficient history | No expected range — too little history | |
| 248 | Insufficient history | No expected range — too little history | |
| 182 | Insufficient history | No expected range — too little history | |
| 192 | Insufficient history | No expected range — too little history | |
| 192 | Insufficient history | No expected range — too little history | |
| 225 | Insufficient history | No expected range — too little history | |
| 201 | Insufficient history | No expected range — too little history | |
| 169 | Insufficient history | No expected range — too little history | |
| 201 | Insufficient history | No expected range — too little history | |
| 183 | Insufficient history | No expected range — too little history | |
| 241 | 115–237 | Above expected (115–237) | |
| 170 | 112–228 | Within expected (112–228) | |
| 213 | 126–256 | Within expected (126–256) | |
| 200 | 141–268 | Within expected (141–268) | |
| 186 | 141–238 | Within expected (141–238) | |
| 215 | 147–245 | Within expected (147–245) | |
| 233 | 235–397 | Below expected (235–397) | |
| 215 | 155–286 | Within expected (155–286) | |
| 282 | 161–299 | Within expected (161–299) | |
| 393 | 170–317 | Above expected (170–317) | |
| 170 | 163–358 | Within expected (163–358) | |
| 206 | 145–372 | Within expected (145–372) | |
| 260 | 152–411 | Within expected (152–411) | |
| 196 | 125–339 | Within expected (125–339) | |
| 205 | 122–364 | Within expected (122–364) |
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 KDI.
Who has entered KDI in the last year?
One company filed in KDI for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Medica USA, Inc. | K243920 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in KDI?
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 KDI?
Across the 345 most recent decisions, these applicants filed most often in KDI.
| Applicant | Recent clearances |
|---|---|
| Nxstage Medical, Inc. | 26 |
| Hospal Medical Corp. | 20 |
| Fresenius Medical Care Renal Therapies Group, LLC | 19 |
| Althin Medical AB an Affiliate of Baxter Intl | 18 |
| Baxter Healthcare Corp | 18 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in KDI files under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Baxter Healthcare Corporation | 26 | 2 |
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. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch KDI
Get an email the morning anything changes in KDI — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
Related product codes in Gastroenterology, Urology
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.