Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Elcam Medical Acal — Predicate Candidate Screening
16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
100 daysmedian FDA review time
259 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231900 | A-TAP (previously called Arthrotap) | Elcam Medical Acal | 2023-07-25 | 27 | 0 |
| K211204 | SafePort(TM) Manifold (or Stopcock) | Elcam Medical Acal | 2022-09-15 | 511 | 0 |
| K190489 | Elcam Stopcocks and Manifolds | Elcam Medical Acal | 2019-04-23 | 54 | 0 |
| K141254 | ELCAM STOPCOCKS AND MANIFOLDS | Elcam Medical Acal | 2014-07-30 | 77 | 0 |
| K123084 | DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK | Elcam Medical Acal | 2013-05-23 | 234 | 0 |
| K120253 | ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS) | Elcam Medical Acal | 2012-07-16 | 171 | 0 |
| K120624 | ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT) | Elcam Medical Acal | 2012-06-08 | 99 | 0 |
| K111467 | FLEXI-Q DV AND DVR AUTO-INJECTORS | Elcam Medical Acal | 2012-02-09 | 259 | 0 |
| K111016 | SAFEPORT MANIFOLD (TM) (OR STOPCOCK) | Elcam Medical Acal | 2011-06-09 | 58 | 12 |
| K100425 | HASKAL TORQUE DEVICE | Elcam Medical Acal | 2010-06-17 | 121 | 0 |
| K082106 | ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS) | Elcam Medical Acal | 2008-10-02 | 69 | 0 |
| K060759 | Y-CLICK CONNECTOR | Elcam Medical Acal | 2006-06-29 | 100 | 0 |
| K053405 | BACSTOP | Elcam Medical Acal | 2006-05-11 | 155 | 0 |
| K060231 | CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-AC | Elcam Medical Acal | 2006-04-13 | 73 | 17 |
| K034043 | H-FLOW VALVE | Elcam Medical Acal | 2004-06-30 | 184 | 0 |
| K032393 | INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK) | Elcam Medical Acal | 2003-09-12 | 39 | 2 |
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