Medical device manufacturer
Baxter Healthcare Corporation
Baxter Healthcare Corporation holds 568 FDA 510(k) clearances across 188 product codes. Median elapsed review time is 85 days. openFDA lists 745 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
- 568
- Product codes
- 188
- Median review
- 85 days
- Recall records
- 745
How does FDA spell Baxter Healthcare Corporation?
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 |
|---|---|---|
| BAXTER HEALTHCARE CORPORATION | device/registrationlisting | normalised |
| BAXTER HEALTHCARE CORPORATION | device/recall | normalised |
| BAXTER HEALTHCARE CORPORATION | device/enforcement | normalised |
| Baxter Healthcare | device/510k | normalised |
| Baxter Healthcare Corp | device/510k | normalised |
| Baxter Healthcare Corp | device/enforcement | normalised |
| Baxter Healthcare Corp | device/recall | normalised |
| Baxter Healthcare Corp. | 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 Baxter Healthcare Corporation file in?
188 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| FPA | Set, Administration, Intravascular | 67 | 78 days | |
| FRN | Pump, Infusion | 51 | 74 days | |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 26 | 108 days | |
| KDJ | Set, Administration, For Peritoneal Dialysis, Disposable | 16 | 86 days | |
| LHI | Set, I.V. Fluid Transfer | 12 | 65 days | |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 10 | 46 days | |
| MQV | Filler, Bone Void, Calcium Compound | 10 | 114 days | |
| FJI | Dialyzer, Capillary, Hollow Fiber | 9 | 72 days | |
| HET | Laparoscope, Gynecologic (And Accessories) | 9 | 104 days | |
| FMI | Needle, Hypodermic, Single Lumen | 8 | 87 days | |
| KPE | Container, I.V. | 8 | 43 days | |
| MEB | Pump, Infusion, Elastomeric | 8 | 59 days | |
| DYG | Catheter, Flow Directed | 7 | 112 days | |
| FKX | System, Peritoneal, Automatic Delivery | 7 | 135 days | |
| JWY | Manual Antimicrobial Susceptibility Test Systems | 7 | 71 days | |
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | 7 | 91 days | |
| FMF | Syringe, Piston | 6 | 89 days | |
| FYA | Gown, Surgical | 6 | 118 days | |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 6 | 60 days | |
| DQO | Catheter, Intravascular, Diagnostic | 5 | 98 days | |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 5 | 190 days | |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 5 | 98 days | |
| GCJ | Laparoscope, General & Plastic Surgery | 5 | 81 days | |
| KGO | Surgeon'S Gloves | 5 | 49 days | |
| KKX | Drape, Surgical, Antimicrobial | 5 | 74 days |
Showing the 25 they file in most, of 188.
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 Baxter Healthcare Corporation had a recall?
openFDA lists 745 recall records naming this company across its whole history, of which 28 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-2548-2026Class IOpen, ClassifiedNHJ
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.
Z-2549-2026Class IOpen, ClassifiedNHJ
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.
Z-2550-2026Class IOpen, ClassifiedNHJ
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.
Z-2551-2026Class IOpen, ClassifiedNHJ
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.
Z-2262-2026Class IIOpen, ClassifiedNEP
Affected lots may contain incorrect 0.8-micron filters. Use of a 0.8-micron filter in place of the validated 3-micron filter may lead to reduced flow efficiency, incomplete or slower transfers of ingredients, or system alarms. This issue may lead to clinical effects such as electrolyte imbalance, metabolic instability, delayed recovery, etc.
Showing the 5 most recently initiated of 745.
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 Baxter Healthcare Corporation cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K251745 | Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) | DXQ | 193 | |
| K251640 | SIGMA Spectrum Infusion Pump with Master Drug Library | FRN | 60 | |
| K251636 | Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) | FRN | 60 | |
| K243529 | Solution Administration Sets | FPA | 120 | |
| K242339 | Intravascular Extension Sets and Accessories | FPA | 205 | |
| K242390 | Novum IQ Syringe Pump (40800BAXUS) | FRN | 24 | |
| K241564 | Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS | MQV | 63 | |
| K230665 | Dose IQ Safety Software | PHC | 385 | |
| K211122 | Novum IQ Large Volume Pump | FRN | 1,079 | |
| K231849 | MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483 | KDJ | 263 |
Source: openFDA device/510k · retrieved
Where is Baxter Healthcare Corporation registered?
FDA lists 6 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 Baxter Healthcare Corporation files next
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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.