Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LDR — Predicate Candidate Screening
60 FDA 510(k) clearances under this product code; the 50 most recent screened below.
57 daysmedian FDA review time
183 days90th percentile
60clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242693 | DEKA Infusion System, DEKA Administration Set | Deka Research and Development Corporation | 2024-10-07 | 28 | 0 |
| K232316 | DEKA Infusion System, DEKA Administration Set | Deka Research and Development | 2024-03-01 | 211 | 0 |
| K153760 | Volumetric Infusion Controller | DEKA Research & Development | 2016-10-03 | 278 | 0 |
| K963136 | PACER MODEL 100 INFUSION CONTROLLER | Health Watch, Inc. | 1997-10-10 | 423 | 0 |
| K971865 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER | Alexander Mfg. Co. | 1997-07-03 | 44 | 0 |
| K971826 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER | Alexander Mfg. Co. | 1997-07-03 | 48 | 0 |
| K934543 | UNIVERSAL CONTROLLER, MODEL 100 | Metamed, Inc. | 1994-03-29 | 194 | 0 |
| K935236 | FLOW CONTROLLING EXTENSION SET | Block Medical, Inc. | 1994-02-24 | 115 | 0 |
| K905497 | MASTER FLOW I.V. PUMPETTE | The Master Medical Corp. | 1991-04-16 | 130 | 0 |
| K905498 | STAT 2 IV PUMPETTE | The Master Medical Corp. | 1991-04-16 | 130 | 4 |
| K896907 | 3M IV FLOW REGULATOR | 3M Company | 1990-02-26 | 80 | 0 |
| K894111 | VARI-SET | Sonex Medical | 1989-09-28 | 108 | 0 |
| K894487 | IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262+ | Y | 1989-09-27 | 71 | 0 |
| K893487 | LIFECARE 75 CONTROLLER | Abbott Laboratories | 1989-07-28 | 85 | 0 |
| K884307 | IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262 | Y | 1988-11-01 | 19 | 0 |
| K882167 | IVY COMMANDER, MODEL 600 | Ivy Medical, Inc. | 1988-09-23 | 122 | 0 |
| K880006 | STA-SET I.V. FLOW REGULATOR | Controlled Flow , Ltd. | 1988-03-24 | 80 | 0 |
| K874916 | TECHNICON CHEM 1(TM) SYSTEM | Technicon Instruments Corp. | 1988-03-03 | 91 | 0 |
| K874481 | IVAC(R) VOLUMETRIC CONTROLLER - MODEL 290 | Y | 1988-03-03 | 122 | 0 |
| K874491 | IVAC(R) SITE-SAVER(R) VOLUMETRIC CONTROLLER - 280+ | Y | 1988-02-25 | 115 | 0 |
| K870820 | IVY COMMANDER (MODEL 500) | Ivy Medical, Inc. | 1988-01-20 | 323 | 0 |
| K870317 | IVAC (R) SITE-SAVER (TM) VOLUMETRIC CONTROLLER 280 | Y | 1987-04-03 | 65 | 0 |
| K870132 | IVAC FLOW CONTROL ADMINISTRATION SET | Y | 1987-02-05 | 24 | 0 |
| K864789 | BETAFLO 2000 PIGGYBACK SYSTEM | Betaflo, Inc. | 1987-02-04 | 58 | 0 |
| K864229 | STA-SET MODEL 250 I.V. FLOW REGULATOR | Sta-Set Corp. | 1986-12-16 | 49 | 0 |
| K863204 | DEKA JR. | Deka Research & Development Corp. | 1986-09-03 | 15 | 0 |
| K862273 | BETAFLO 2000 | Betaflo, Inc. | 1986-07-18 | 32 | 0 |
| K855000 | RATEMINDER III INFUSION DEVICE | American Edwards Laboratories | 1986-02-12 | 61 | 0 |
| K854863 | FLO-GARD 4000 VOLUMETRIC INFUSION CONTROLLER | Travenol Laboratories, S.A. | 1986-02-12 | 69 | 0 |
| K851058 | DOSI FLOW | Leventon, S.A. | 1985-04-29 | 46 | 1 |
| K842209 | ARM-A-FLOW INTRAVENOUS FLOW REGULATOR | Armour Pharmaceutical Co. | 1984-12-04 | 183 | 0 |
| K843254 | DK*300 VOLUMETRIC INFUSION CONTROLLER | Deka Research & Development Corp. | 1984-10-11 | 52 | 0 |
| K842419 | IVAC 280 VOLUMETRIC INFUSION CONTROLLER | Y | 1984-08-07 | 48 | 0 |
| K842210 | IVENT 302VC DUAL CONTROLLER | Ivent Corp. | 1984-07-25 | 51 | 0 |
| K841318 | A.S.A.P. | Trimedyne, Inc. | 1984-07-18 | 107 | 0 |
| K842080 | ABBOTT LIFECARE 1050 CONTROLLER | Abbott Laboratories | 1984-07-18 | 56 | 0 |
| K834106 | INTRAVENOUS INFUSION CONTROLLER | Cutter Laboratories, Inc. | 1984-05-30 | 183 | 0 |
| K840942 | IVY COMMANDEER | Ivy Medical, Inc. | 1984-03-30 | 25 | 0 |
| K840644 | FLO-GARD 4000 VOLUMETRIC INFUSION | Travenol Laboratories, S.A. | 1984-03-23 | 37 | 0 |
| K840823 | TREONIC C30 | Vickers America Medical Corp. | 1984-03-23 | 28 | 0 |
| K834528 | MODEL 2001 INTELLIGENT INFUSOR | Quest Medical, Inc. | 1984-02-21 | 62 | 0 |
| K834154 | FLO-GARD 8000 COMPUTER CONTROL INFUSI | Travenol Laboratories, S.A. | 1984-01-25 | 54 | 0 |
| K833953 | ELECTRONIC GRAVITY 300VC | Ivent Corp. | 1983-12-29 | 43 | 0 |
| K833520 | RATEMINDER II SPECIALTY CARE | Anatros Corp. | 1983-12-22 | 72 | 0 |
| K832739 | STEDIFLO INFUSION SET | Dravon Medical, Inc. | 1983-12-22 | 129 | 0 |
| K833682 | PRIMARY PIGGYBACK INFUSION SET W/PERM | Cosmetic Sciences, Inc. | 1983-11-28 | 28 | 0 |
| K832702 | POCKET AID | M.C. Johnson Co., Inc. | 1983-11-17 | 98 | 0 |
| K830780 | KOALA C99 I.V. CONTROLLER | Chesebrough-Pond'S U.S.A. Co. | 1983-04-08 | 28 | 0 |
| K823404 | VOLUMERIC CONTROLLER | Quest Medical, Inc. | 1982-12-22 | 37 | 0 |
| K822891 | FLO CONTROL | Dna Medical, Inc. | 1982-11-24 | 57 | 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