Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Analogic Corp. — Predicate Candidate Screening
32 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
204 days90th percentile
32clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K071430 | SYNERAD OMNI, MODELS AN6255 AND AN6265 | Analogic Corp. | 2007-06-21 | 29 | 0 |
| K052447 | SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600 | Analogic Corp. | 2005-09-21 | 14 | 0 |
| K050919 | LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN | Analogic Corp. | 2005-06-14 | 63 | 0 |
| K043025 | SYNERAD OMNI, DIGITAL X-RAY SYSTEM, MODEL AN6250 | Analogic Corp. | 2004-11-19 | 16 | 0 |
| K041434 | C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORS | Analogic Corp. | 2004-08-06 | 70 | 0 |
| K041376 | C1 SERIES PATIENT MONITOR, MODELS 863051, 863052, 863053, 86 | Analogic Corp. | 2004-07-20 | 57 | 0 |
| K040995 | SYNERAD MULTI DIGITAL X-RAY SYSTEM, MODEL AN6150 | Analogic Corp. | 2004-05-25 | 39 | 1 |
| K033345 | AN5150 AND AN7150 DIGITAL RADIOLOGY SYSTEMS | Analogic Corp. | 2003-11-19 | 30 | 0 |
| K030931 | C3 PATIENT MONITOR | Analogic Corp. | 2003-05-09 | 45 | 0 |
| K011304 | OB-1 FETAL MONITOR | Analogic Corp. | 2001-05-29 | 29 | 0 |
| K002503 | FETALGARD LITE | Analogic Corp. | 2000-11-09 | 87 | 0 |
| K001336 | DR9000 DIGITAL RADIOGRAPHY X-RAY SYSTEM | Analogic Corp. | 2000-06-02 | 36 | 0 |
| K001341 | DR5000 DEDICATED CHEST X-RAY SYSTEM | Analogic Corp. | 2000-06-02 | 36 | 2 |
| K983395 | FETALGARD 3000 FETAL MONITOR | Analogic Corp. | 1999-08-12 | 321 | 0 |
| K991626 | WEBRAD COMPUTED RADIOGRAPHY QUALITY ASSURANCE WORKSTATION | Analogic Corp. | 1999-07-02 | 52 | 0 |
| K980411 | NPB3900 SERIES PATIENT MONITORS | Analogic Corp. | 1998-08-20 | 198 | 0 |
| K980168 | COMPUTED RADIOGRAPHY QUALITY ASSURANCE SOFTWARE | Analogic Corp. | 1998-04-02 | 76 | 0 |
| K974455 | ANATOM 1000 (A MINUS, A-) | Analogic Corp. | 1998-02-20 | 87 | 0 |
| K964890 | ANATOM 2000 | Analogic Corp. | 1997-03-06 | 90 | 0 |
| K962424 | NPB-4000 | Analogic Corp. | 1996-12-20 | 179 | 0 |
| K950420 | FETALGARD 3000 - MODELS IP1, IP2, AP2 AND AP3 | Analogic Corp. | 1995-05-15 | 104 | 0 |
| K944131 | ANATOM 2000 | Analogic Corp. | 1995-01-25 | 154 | 0 |
| K933103 | DIGITAL IMAGE COMMUNICATIONS SYSTEM | Analogic Corp. | 1993-10-05 | 103 | 0 |
| K910169 | FETALGARD 2000 | Analogic Corp. | 1991-07-22 | 188 | 0 |
| K860646 | PATIENT MON 1280/1281/120C/121C & MULTI-PARA CART | Analogic Corp. | 1986-10-16 | 238 | 0 |
| K855096 | SIEMENS SIRECUST MODELS 403P,403-2P & 403N | Analogic Corp. | 1986-07-15 | 204 | 0 |
| K844791 | SYSTEM SIRECUST 400 SIEMENS SIRECUST 456-1A | Analogic Corp. | 1985-04-10 | 121 | 0 |
| K831319 | PATIENT MONITOR #404 | Analogic Corp. | 1984-03-22 | 335 | 0 |
| K830029 | SIRECUST 400 | Analogic Corp. | 1983-03-31 | 86 | 0 |
| K830028 | SIRECUST 456 | Analogic Corp. | 1983-01-21 | 17 | 0 |
| K822091 | SIEMENS SIRECUST SYSTEM | Analogic Corp. | 1982-10-18 | 95 | 0 |
| K802113 | SIRECUST 400 SYSTEM PATIENT MONITORING | Analogic Corp. | 1981-01-22 | 141 | 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