Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biomedical Life Systems, Inc. — Predicate Candidate Screening
35 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
165 daysmedian FDA review time
275 days90th percentile
35clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K172971 | BMLS16-1 | Biomedical Life Systems, Inc. | 2018-07-08 | 285 | 0 |
| K102051 | PAIN BUDDY | Biomedical Life Systems, Inc. | 2011-07-29 | 373 | 0 |
| K061476 | ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS06-1 | Biomedical Life Systems, Inc. | 2006-07-26 | 57 | 0 |
| K042711 | MODEL BMLS03-7 | Biomedical Life Systems, Inc. | 2005-03-14 | 165 | 0 |
| K041388 | COMBINATION POWERED ELECTRICAL MUSCLE STIMULATOR AND INTERFE | Biomedical Life Systems, Inc. | 2004-11-23 | 182 | 0 |
| K040007 | INTERFERENTIAL STIMULATOR, MODEL BMLS02-6 | Biomedical Life Systems, Inc. | 2004-07-07 | 187 | 0 |
| K033174 | BMLS03-3 | Biomedical Life Systems, Inc. | 2004-06-30 | 273 | 0 |
| K040824 | INTERFERENTIAL STIMULATOR, MODEL BMLS03-6 | Biomedical Life Systems, Inc. | 2004-04-29 | 30 | 0 |
| K040306 | HIGH VOLTAGE PULSED STIMULATOR, MODEL BMLS02-7 | Biomedical Life Systems, Inc. | 2004-03-23 | 43 | 0 |
| K033455 | ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5 | Biomedical Life Systems, Inc. | 2004-01-15 | 77 | 0 |
| K031427 | ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS03-1 | Biomedical Life Systems, Inc. | 2003-08-19 | 105 | 0 |
| K021588 | ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS02-5 | Biomedical Life Systems, Inc. | 2003-02-13 | 275 | 0 |
| K022841 | ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS02-9 | Biomedical Life Systems, Inc. | 2002-11-19 | 84 | 0 |
| K022925 | ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-10 | Biomedical Life Systems, Inc. | 2002-11-19 | 76 | 0 |
| K020712 | ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-4 | Biomedical Life Systems, Inc. | 2002-09-24 | 203 | 0 |
| K010749 | ELECTRO NEUROMUSCULAR STIMULATOR, MODEL NMS-DIGITAL | Biomedical Life Systems, Inc. | 2001-09-28 | 199 | 0 |
| K010209 | ELECTRO-NERVE STIMULATOR TENS, MODEL HE-DIGITAL | Biomedical Life Systems, Inc. | 2001-06-12 | 140 | 0 |
| K990230 | ELECTRO-NERVE STIMULATOR TENS, MODEL LX | Biomedical Life Systems, Inc. | 1999-08-19 | 206 | 0 |
| K932916 | GALVANIC GENERATOR MODEL IMF4150/A | Biomedical Life Systems, Inc. | 1994-01-07 | 205 | 0 |
| K925687 | INTERFERENTIAL STIMULATOR MODEL IMF4150/A | Biomedical Life Systems, Inc. | 1993-03-29 | 137 | 0 |
| K925686 | THERA PULSE A ELECTRO NERVE STIMULATOR | Biomedical Life Systems, Inc. | 1993-03-18 | 126 | 0 |
| K921441 | INTERFERENTIAL STIMULATOR MODEL INF 4150/A | Biomedical Life Systems, Inc. | 1992-05-08 | 44 | 0 |
| K915210 | ELECTRO-NERVE STIMULATOR TENS MODEL MICRO PLUS-A | Biomedical Life Systems, Inc. | 1992-05-04 | 168 | 0 |
| K905569 | ELECTRO-NERVE STIMULATOR TENS,MODEL SYSTEMS PLUS/A | Biomedical Life Systems, Inc. | 1991-06-27 | 197 | 0 |
| K905570 | ELECTRO-NERVE STIMULATOR TENS MODEL BIOMED 2000/A | Biomedical Life Systems, Inc. | 1991-06-04 | 174 | 0 |
| K905377 | ELECTRO-NERVE STIMULATOR TENS MODEL SYSTEMS 2000/A | Biomedical Life Systems, Inc. | 1991-06-04 | 186 | 0 |
| K905230 | ELECTRO-NEVE STIMULATOR TENS MODEL BIOMED PLUS/A | Biomedical Life Systems, Inc. | 1991-06-04 | 196 | 0 |
| K905571 | ELECTRO-NERVE STIMULATOR TENS MODEL,INF 4150/A | Biomedical Life Systems, Inc. | 1991-05-08 | 147 | 0 |
| K884651 | ELECTRO NEUROMUSCULAR STIMULATOR MODEL 2000 | Biomedical Life Systems, Inc. | 1989-11-06 | 364 | 0 |
| K871126 | ELECTRO-NERVE STIMULATOR TENS MODEL C & B11, B11C | Biomedical Life Systems, Inc. | 1987-06-02 | 74 | 0 |
| K871125 | ELECTRO-NERVE STIMULATOR TENS MODEL B5/SKN | Biomedical Life Systems, Inc. | 1987-06-02 | 74 | 0 |
| K851191 | ELECTRO-NERVE STIMULATOR DISCO B9 TENS | Biomedical Life Systems, Inc. | 1985-05-31 | 91 | 0 |
| K851185 | ELECTRO-NERVE STIMULATOR B4/B400 | Biomedical Life Systems, Inc. | 1985-05-23 | 83 | 0 |
| K844076 | ELECTRO-NERVE STIMULATOR B5/SK700B | Biomedical Life Systems, Inc. | 1985-01-23 | 96 | 0 |
| K841184 | ELECTRO-NERVE STIMULATOR HL | Biomedical Life Systems, Inc. | 1984-10-04 | 198 | 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