Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KZD — Predicate Candidate Screening
35 FDA 510(k) clearances under this product code; the 50 most recent screened below.
48 daysmedian FDA review time
150 days90th percentile
35clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K974074 | INFUSION DYNAMICS POWER INFUSER | Infusion Dynamics, Inc. | 1998-02-17 | 111 | 0 |
| K973843 | MSI PRESSURE INFUSOR | Smith Assoc. | 1997-10-29 | 21 | 0 |
| K953290 | OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMP | Olympus America, Inc. | 1995-10-07 | 85 | 0 |
| K951988 | PRESSURIZER | Promedic, Inc. | 1995-06-14 | 48 | 0 |
| K942933 | PRESSURE INFUSION CUFF | Circulatory Technology, Inc. | 1994-08-25 | 64 | 0 |
| K930012 | KAWASUMI LABORATORIES K-CUFF | Kawasumi Laboratories Co., Ltd. | 1993-12-14 | 344 | 0 |
| K921168 | ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000 | Allen Medical Systems, Inc. | 1993-04-21 | 407 | 0 |
| K913751 | PRESSURE INFUSER | Biomedical Dynamics, Inc. | 1992-01-09 | 141 | 0 |
| K910926 | TECNADYNE SURGI-SQUEEZE INFUSION PUMP | Tecnadyne Scientific, Inc. | 1991-08-02 | 150 | 0 |
| K911216 | INFUSABLE | Biomedical Dynamics, Inc. | 1991-07-22 | 125 | 0 |
| K904484 | BAXTER SINGLE PATIENT USE PRESSURE INFUSOR | Tecnadyne Scientific, Inc. | 1990-10-26 | 24 | 0 |
| K901225 | LIFE SHIELD (DISPOSABLE PRESSURE INFUSOR) | Abbott Laboratories | 1990-08-23 | 162 | 0 |
| K894927 | SURGI SQUEEZ | Ethox Corp. | 1989-09-11 | 40 | 0 |
| K881977 | PRESSURE INFUSOR | Primrose Medical, Inc. | 1988-07-29 | 79 | 0 |
| K874454 | IV-PUSH, CONSTANT INFUSION PUMP | Medical Products Search, Inc. | 1987-11-06 | 9 | 0 |
| K861977 | BIOMEDICAL DYNAMICS DISPOSABLE PRESSURE INFUSOR | Biomedical Dynamics, Inc. | 1986-07-15 | 55 | 0 |
| K854807 | LIFE PAC | Lifemed Technologies, Inc. | 1986-04-15 | 133 | 0 |
| K855054 | THE WOOD PUMP 'OLE RED' | T.C. Retigo, Inc. | 1986-03-18 | 91 | 0 |
| K860084 | PRESSURE INFUSOR #1900 | Pa Medical Corp. | 1986-03-18 | 68 | 0 |
| K851904 | DATA TRAC ANESTHESIOLOGY RECORDER | Datascope Corp. | 1985-05-10 | 10 | 0 |
| K832377 | BIOCUFF INFUSION BAG PRESSOR | Bio-Medical Instruments , Ltd. | 1983-08-12 | 24 | 0 |
| K822434 | CREST PRESSURE INFUSOR | Crest Medical Equipment | 1982-09-17 | 35 | 0 |
| K822286 | AUTOCUFF (PHOTOS ENCLOSED WITH 510K | Partamed, Inc. | 1982-08-27 | 28 | 0 |
| K820159 | PRESSURE INFUSER | David Clark Company, Inc. | 1982-04-21 | 91 | 0 |
| K813105 | PRESSURE INFUSION PUMP | Calbio, Inc. | 1981-12-14 | 41 | 0 |
| K810954 | NORFOLK/NORWICH PRESSURE INFUSION BOX | Medical Innovations Corp. | 1981-04-21 | 14 | 0 |
| K800560 | MX820-5 PRESSURE INFUSOR 500CC MX820-10 | Medex, Inc. | 1980-04-29 | 48 | 0 |
| K781037 | PRESSURE INFUSION DEVICE | Hinck Medical, Inc. | 1978-09-14 | 87 | 0 |
| K780465 | VOLUME CONTROL DEVICE VCD-150 | Sorensen Research | 1978-06-02 | 72 | 0 |
| K771458 | INFUSION ACCELERATOR | Terumo America, Inc. | 1977-08-26 | 22 | 0 |
| K770758 | INJECTION SYSTEM, MDC I.V. | Medical Development Co. | 1977-05-20 | 25 | 0 |
| K760895 | AUTOMATIC SHUT-OFF VALVE | Delta Medical Industries | 1976-12-09 | 44 | 0 |
| K760483 | BLOOD-SOLUTION ADMINISTRATION SET, SURG. | Travenol Laboratories, S.A. | 1976-09-03 | 14 | 0 |
| K760505 | SOLUTION ADMINISTRATION SET (#2C0631) | Travenol Laboratories, S.A. | 1976-09-03 | 11 | 0 |
| K760313 | KIT, PREP, INSPIRON IV | Inspiron Corp. | 1976-08-04 | 9 | 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