Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Pharmaseal Div., Baxter Healthcare Corp. · Predicate Candidate Screening
24 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
58 days90th percentile
24clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K792369 | HYPERALIMENTATION DRESSING TRAY | Pharmaseal Div., Baxter Healthcare Corp. | 1979-12-10 | 77 | 0 |
| K792141 | CONTINUOUS FLUSH DEVICE | Pharmaseal Div., Baxter Healthcare Corp. | 1979-12-05 | 44 | 0 |
| K792019 | PHADECODE XA INHIBITOR ASSAY | Pharmaseal Div., Baxter Healthcare Corp. | 1979-11-05 | 27 | 0 |
| K791773 | VENTILATOR TUBE WITH FILTER | Pharmaseal Div., Baxter Healthcare Corp. | 1979-10-22 | 42 | 0 |
| K791156 | AMIPAQUE MYELOGRAM TRAY | Pharmaseal Div., Baxter Healthcare Corp. | 1979-07-30 | 39 | 0 |
| K790896 | TWO-WAY ANESTHESIA FILTER | Pharmaseal Div., Baxter Healthcare Corp. | 1979-06-05 | 28 | 0 |
| K790409 | LOW DEAD SPACE INSULIN SYRINGE | Pharmaseal Div., Baxter Healthcare Corp. | 1979-04-24 | 57 | 0 |
| K782069 | TRAY, AUXILLARY BLOCK | Pharmaseal Div., Baxter Healthcare Corp. | 1979-01-04 | 22 | 0 |
| K781797 | PREP TRAY, PREOPERATIVE SKIN | Pharmaseal Div., Baxter Healthcare Corp. | 1978-11-08 | 16 | 0 |
| K781680 | MONITORING, PRESSURE KIT | Pharmaseal Div., Baxter Healthcare Corp. | 1978-10-06 | 4 | 0 |
| K780887 | IMPROVED DISPOSABLE HYPODERMIC NEEDLE | Pharmaseal Div., Baxter Healthcare Corp. | 1978-06-22 | 27 | 0 |
| K771810 | PRESSURE TUBING | Pharmaseal Div., Baxter Healthcare Corp. | 1977-11-17 | 51 | 0 |
| K771359 | ALLERGIST PACK SYRINGES | Pharmaseal Div., Baxter Healthcare Corp. | 1977-08-22 | 28 | 0 |
| K770942 | PHADECODE DIFFERENTIAL FACTOR XA1 ASSAY | Pharmaseal Div., Baxter Healthcare Corp. | 1977-07-21 | 58 | 0 |
| K770489 | CATHETER WITH HARD VALVE | Pharmaseal Div., Baxter Healthcare Corp. | 1977-03-21 | 7 | 0 |
| K770490 | DRAINAGE BAG, IMPROVED, FLAT | Pharmaseal Div., Baxter Healthcare Corp. | 1977-03-21 | 7 | 0 |
| K770108 | TUBE HOLDING DEVICE | Pharmaseal Div., Baxter Healthcare Corp. | 1977-03-10 | 52 | 0 |
| K770149 | MAJOR SUTURE REMOVAL TRAY | Pharmaseal Div., Baxter Healthcare Corp. | 1977-02-25 | 32 | 0 |
| K770256 | CATHETERS, SILICONE COATED | Pharmaseal Div., Baxter Healthcare Corp. | 1977-02-17 | 7 | 0 |
| K770120 | MOUTH WASH TRAY | Pharmaseal Div., Baxter Healthcare Corp. | 1977-01-28 | 7 | 0 |
| K761158 | FLUID DISPENSING SYSTEM | Pharmaseal Div., Baxter Healthcare Corp. | 1977-01-26 | 58 | 0 |
| K761230 | AMMOCENTESIS TRAY (KIT) | Pharmaseal Div., Baxter Healthcare Corp. | 1976-12-17 | 7 | 0 |
| K761039 | URINARY LEG BAG DRAINAGE TUBE | Pharmaseal Div., Baxter Healthcare Corp. | 1976-12-02 | 17 | 0 |
| K760069 | BAG, LEG, URINE COLLECTING DEVICE | Pharmaseal Div., Baxter Healthcare Corp. | 1976-10-20 | 126 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda