Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hill-Rom, Inc. — Predicate Candidate Screening
33 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
179 daysmedian FDA review time
294 days90th percentile
33clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K202018 | Hill-Rom Heart and Respiration Rate Monitoring System: Singl | Hill-Rom, Inc. | 2021-03-04 | 226 | 0 |
| K180079 | Hill-Rom Vitals Monitoring System powered by EarlySense: Sen | Hill-Rom, Inc. | 2018-05-07 | 117 | 0 |
| K013709 | HILL-ROM PRIMAVIEW MONITOR SYSTEM | Hill-Rom, Inc. | 2001-11-16 | 8 | 0 |
| K973705 | CONTOR TABLE SURFACE | Hill-Rom, Inc. | 1998-08-07 | 312 | 0 |
| K981081 | BRIGHTSTAR | Hill-Rom, Inc. | 1998-04-29 | 36 | 0 |
| K972111 | RUMORS DYNAMIC AIR THERAPY UNIT | Hill-Rom, Inc. | 1998-02-02 | 242 | 0 |
| K971366 | INCUWARMER | Hill-Rom, Inc. | 1998-01-05 | 266 | 0 |
| K970636 | TOTALCARE., MODULAR THERAPY SYSTEM (MTS) | Hill-Rom, Inc. | 1997-08-26 | 187 | 1 |
| K964873 | SILKAIR LOW AIRLOSS THERAPY | Hill-Rom, Inc. | 1997-07-03 | 210 | 0 |
| K964223 | CLINITRON RITE-HITE | Hill-Rom, Inc. | 1997-05-28 | 217 | 2 |
| K970295 | FLEXICAIR EXLIPSE PLUS | Hill-Rom, Inc. | 1997-05-16 | 109 | 0 |
| K970074 | STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1 | Hill-Rom, Inc. | 1997-04-03 | 85 | 0 |
| K962942 | TOTALCARE | Hill-Rom, Inc. | 1997-02-03 | 189 | 0 |
| K963091 | VOLLMAN PRONE POSITIONER | Hill-Rom, Inc. | 1997-01-09 | 154 | 0 |
| K961437 | WHEELED STRETCHER | Hill-Rom, Inc. | 1996-06-03 | 49 | 0 |
| K952447 | HILL-ROM AMBULATORY CARE PROCEDURAL STRETCHER | Hill-Rom, Inc. | 1995-11-22 | 181 | 0 |
| K951001 | FLEXICAIR EXLIPSE | Hill-Rom, Inc. | 1995-06-27 | 116 | 0 |
| K950756 | PULMONEX DYNAMIC AIR THERAPY UNIT | Hill-Rom, Inc. | 1995-05-30 | 102 | 0 |
| K944580 | FLEXSYS MOBILEMATE EQUIPMENT STAND | Hill-Rom, Inc. | 1995-03-17 | 179 | 0 |
| K945729 | DYNAMICAIRE(TM) SLEEP SURFACE, ZONEAIR(TM) SLEEP SURFACE | Hill-Rom, Inc. | 1995-02-27 | 97 | 0 |
| K942904 | STABILET | Hill-Rom, Inc. | 1994-09-16 | 87 | 0 |
| K924420 | MEDICAL DISPOSABLE BEDDING | Hill-Rom, Inc. | 1993-12-10 | 465 | 0 |
| K926140 | VACUUM POWER BODY FLUID SUCTION APPARATUS | Hill-Rom, Inc. | 1993-07-27 | 232 | 0 |
| K922808 | HILL-ROM VIA STRETCHER (P1300 - P1303) | Hill-Rom, Inc. | 1993-03-31 | 294 | 0 |
| K922809 | GENERAL PROCEDURAL STRETCHERS (P880- P886) | Hill-Rom, Inc. | 1993-03-31 | 294 | 0 |
| K915779 | AFFINITY BED MODEL 3600 SERIES | Hill-Rom, Inc. | 1993-02-24 | 428 | 10 |
| K922352 | THE ADVANCE SERIES FROM HILL-ROM | Hill-Rom, Inc. | 1992-10-13 | 147 | 0 |
| K915437 | CRITICAL CARE HOSPITAL BED (ICU/CCU) | Hill-Rom, Inc. | 1992-06-11 | 198 | 0 |
| K914309 | THE GENESIS BED FROM HILL-ROM, MODEL 355 SERIES | Hill-Rom, Inc. | 1992-04-20 | 208 | 0 |
| K921528 | HILL-ROM PATIENT ENVIRONMENTAL CONTROL SYSTEM | Hill-Rom, Inc. | 1992-04-20 | 18 | 0 |
| K913945 | STABILET INFANT RADIANT WARMER MODEL 2000C | Hill-Rom, Inc. | 1992-02-12 | 161 | 1 |
| K864186 | HILL-ROM CENTURY CC MODELS 892 &894 (RADIOLUCENT) | Hill-Rom, Inc. | 1986-11-13 | 17 | 0 |
| K864172 | HILL-ROM CENTURY CC, MODELS 891 & 893 WEIGHING SYS | Hill-Rom, Inc. | 1986-11-13 | 20 | 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